VARIOUS MONITORS MANUFACTURED BY GYRUS ACMI L.P.

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Request for Information Form	Contact Information
Company Name	GYRUS ACMI L.P.
Address	6845 WEDGEWOOD RD.
City, State, Zip	MAPLE GROVE, MN 55311
Country	US
FDA Owner/Operator Phone	011-44-189219750
FDA Medical Specialty Code	SU - General Plastic Surgery
FDA Product Code	FWG
FDA Classification Name	CAMERA, TELEVISION, ENDOSCOPIC, WITH AUDIO
FDA Device Classification Code	General Controls
FDA Regulation Number	878.4160
FDA Common Generic Name	CAMERA, TELEVISION, ENDOSCOPIC, WITH AUDIO
FDA Proprietary Device Name	VARIOUS MONITORS
FDA Owner / Operator Number	9018965
FDA Owner / Operator Name	GYRUS GROUP PLC
FDA Establishment Registration Number	117977
FDA Registered Establishment Name	GYRUS ACMI L.P.
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	08-27-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	ACUEITY, INC. 100 HAMILTON AVE., SUITE 140 PALO ALTO, CA 94301 US 650-473-9910 / 650-759-6186	VIADUCT CAMERA	CAMERA MONITOR
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3	ATMOS MEDIZINTECHNIK GMBH & CO. KG LUDWIG-KEGEL-STRASSE 16 LENZKIRCH, 79853 GM 011-497-653-689 0 / 610-740-1011	MULTIPLE CAMERAS	VARIOUS TYPES/MODELS OF EAR, NOSE, THROAT DIGITAL COLOUR VIDEO CAMERA WITH TV
4	BIOMET SPORTS MEDICINE 6704 LOCKHEED DR. REDDING, CA 96002 US 574-267-6639 / 530-226-5800	CAMERA	CAMERA, VARIOUS SIZES AND TYPES, ENDOSCOPIC
5	INTEGRA NEURO SCIENCES 5955 PACIFIC CENTER BLVD. SAN DIEGO, CA 92121 US 609-275-0500 / 858-455-1115 115	NEUROVIEW SYSTEM	INTEGRATED VISUALIZATION SYSTEM
6	MAHE MEDICAL GMBH FRIEDRICH-WOEHLER-STR. 10 EMMINGEN-LIPTINGEN, 78576 GM 49-746-5 9275 0 / 49-746-5 92750	MAHE	CAMERA, TV
7	MEDICAL SUPPLY CO. 2227 EAST CRESCENT DR. ALTADENA, CA 91001 US 626-798-3913 / 626-798-3913	SYSTEM 9000	ENDOSCOPIC VIDEO CAMERA
8	NAGASHIMA MEDICAL INSTRUMENTS CO., LTD. 24-1 HONGO, 5-CHOME BUNKYO-KU, TOKYO, JA 813-381-26555 / 813-381-2-6555	MULTIPLE	VARIOUS