FDA Product Classification Codes Begining with "O"

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FDA Device Classification	Medical Specialty	FDA Product Code	FDA Regulation Number	Device Class	510k Exempt?
OBTURATOR, FOR ENDOSCOPE	Gastroenterology/Urology	FEC	876.1500	2	N
OCCLUDER, BALLOON, VENA-CAVA	Cardiovascular	LWT		3	N
OCCLUDER, CATHETER TIP	Cardiovascular	DQT	870.1370	2	N
OCCLUDER, PATENT DUCTUS, ARTERIOSUS	Cardiovascular	MAE		3	N
OCULAR PEG	Opthalmic	MQU	886.3320	2	N
OIL EMULSION/THYMOLPHTHALEIN (TITRIMETRIC), LIPASE	Clinical Chemistry	CFG	862.1465	1	Y
OIL RED O	Pathology	HZG	864.1850	1	Y
OIL, CLEARING	Pathology	IJZ	864.4010	1	Y
OLIVE OIL EMULSION (TURBIDIMETRIC), LIPASE	Clinical Chemistry	CET	862.1465	1	Y
ONCOMETER, PLASMA, FOR CLINICAL USE	Clinical Chemistry	JJK	862.2720	1	Y
OOCYTE ASPIRATION NEEDLES	Obstetrics/Gynecology	MHK		3	N
O-PHTHALALDEHYDE, UREA NITROGEN	Clinical Chemistry	JGZ	862.1770	2	N
OPHTHALMOSCOPE, AC-POWERED	Opthalmic	HLI	886.1570	2	N
OPHTHALMOSCOPE, BATTERY-POWERED	Opthalmic	HLJ	886.1570	2	N
OPHTHALMOSCOPE,LASER,SCANNING	Opthalmic	MYC	886.1570	2	N
OPHTHALMOSCOPES,REPLACEMENT BATTERIES,HAND-HELD	Opthalmic	MSG			N
ORANGE G	Pathology	HZH	864.1850	1	Y
ORANGE II	Pathology	KKE	864.1850	1	Y
ORCEIN	Pathology	KKF	864.1850	1	Y
ORTHOPEDIC IMPLANT MATERIAL	Orthopedic	MOO			N
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	LXH	888.4540	1	Y
ORTHOSIS, ABDOMINAL	Physical Medicine	KTD	890.3490	1	Y
ORTHOSIS, CERVICAL	Physical Medicine	IQK	890.3490	1	Y
ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION	Orthopedic	NKG			N
ORTHOSIS, CERVICAL-THORACIC, RIGID	Physical Medicine	IQF	890.3490	1	Y
ORTHOSIS, CORRECTIVE SHOE	Physical Medicine	KNP	890.3475	1	Y
ORTHOSIS, CRANIAL	Neurology	MVA	882.5970	2	N
ORTHOSIS, LIMB BRACE	Physical Medicine	IQI	890.3475	1	Y
ORTHOSIS, LUMBAR	Physical Medicine	IQE	890.3490	1	Y
ORTHOSIS, LUMBO-SACRAL	Physical Medicine	IPY	890.3490	1	Y
ORTHOSIS, MOLDABLE, SUPPORTIVE, SKIN PROTECTIVE	Physical Medicine	MNE			N
ORTHOSIS, PEDICLE SCREW SPINAL SYSTEM, SPONDYLOSIS AND FACET DEGENERATION	Orthopedic	NKH			N
ORTHOSIS, PNEUMATIC STRUCTURE, RIGID	Physical Medicine	IPO	890.3610	3	N
ORTHOSIS, RIB FRACTURE, SOFT	Physical Medicine	IPX	890.3490	1	Y
ORTHOSIS, SACROILIAC, SOFT	Physical Medicine	IPW	890.3490	1	Y
ORTHOSIS, SPINAL INTERVERTEBRAL FUSION	Orthopedic	MAX			N
ORTHOSIS, SPINAL PEDICLE FIXATION	Orthopedic	MNI	888.3070	2	N
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	Orthopedic	NKB	888.3070	3	N
ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION	Orthopedic	MNH	888.3070	2	N
ORTHOSIS, THORACIC	Physical Medicine	IPT	890.3490	1	Y
ORTHOSIS, TRUNCAL, FOR DYSMENORRHEA	Physical Medicine	NJB	890.3490	1	Y
ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB	Physical Medicine	MRI	890.3490	1	Y
ORTHOTOLUIDINE, GLUCOSE	Clinical Chemistry	CGE	862.1345	2	N
OSCILLOMETER	Cardiovascular	DRZ	870.2675	2	N
OSMIUM TETROXIDE	Pathology	KEE	864.4010	1	Y
OSMOMETER FOR CLINICAL USE	Clinical Chemistry	JJM	862.2730	1	Y
OSMOTIC FRAGILITY TESTING	Hematology	GKE	864.6600	1	Y
OSTEOTOME	General Plastic Surgery	HWM	878.4800	1	Y
OSTEOTOME, MANUAL	General Plastic Surgery	GFI	878.4800	1	Y
OTOSCOPE	Ear, Nose, Throat	ERA	874.4770	1	Y
OVENS, PARAFFIN	Pathology	IDR	864.3010	1	Y
OXALYDIHYDRAZIDE (SPECTROSCOPIC), COPPER	Clinical Chemistry	JKY	862.1190	1	Y
OXIMETER	Anesthesiology	DQA	870.2700	2	N
OXIMETER TO MEASURE HEMOGLOBIN	Hematology	GLY	864.7500	2	N
OXIMETER, EAR	Anesthesiology	DPZ	870.2710	2	N
OXIMETER, FETAL PULSE	Obstetrics/Gynecology	MMA		3	N
OXIMETER, REPROCESSED	Anesthesiology	NLF	870.2700	2	N
OXIMETER, TISSUE SATURATION	Anesthesiology	MUD	870.2700	2	N
OXIMETER, TISSUE SATURATION, REPROCESSED	Cardiovascular	NMD	870.2700	2	N
OXYGENATOR, CARDIOPULMONARY BYPASS	Cardiovascular	DTZ	870.4350	2	N
OXYHEMOGLOBIN	Hematology	GGZ	864.7500	2	N

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