3T/SEWOON SILICONE FOLEY BALLOON CATHETERS MANUFACTURED BY SEWOON MEDICAL CO., LTD.

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Request for Information Form	Contact Information
Company Name	SEWOON MEDICAL CO., LTD.
Address	344-14, DORIM-RI, IPJANG-MYEON CHEONAN-SI, CHUNGCHEONGNAM-DO
City, State, Zip	SEOUL,
Country	KS
FDA Owner/Operator Phone	82-41-58429036
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	MJC
FDA Classification Name	CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
FDA Device Classification Code	Standards
FDA Regulation Number	876.5130
FDA Common Generic Name	ALL SILICONE FOLEY BALLOON CATHETER WITH AND WITH OUT TEMPERATURE SENSOR
FDA Proprietary Device Name	3T/SEWOON SILICONE FOLEY BALLOON CATHETERS
FDA Owner / Operator Number	9036109
FDA Owner / Operator Name	SEWOON MEDICAL CO., LTD.
FDA Establishment Registration Number	3000247987
FDA Registered Establishment Name	SEWOON MEDICAL CO., LTD.
FDA Operation Code(s)
FDA Listing Date	01-08-03
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	C.R. BARD, INC. 1211 MARY MAGNAN BLVD. MADISON, GA 30650 US 908-277-8000 / 908-277-8513	BARDEX IC	ANTIMICROBIAL FOLEY CATHETER, TEMP-SENSING SILVER-HYDROGEL
2	C.R. BARD, INC. 428 POWERHOUSE RD. MONCKS CORNER, SC 29461 US 908-277-8000 / 908-277-8513	BARDEX I.C.	VARIOUS
3	PRODUCTOS PARA EL CUIDADO DE LA SALUD KM. 7 CARRETERA INTERNACIONAL NOGALES, SONORA, MX 908-277-8000 / 908-277-8513	BARDEX I.C.	VARIOUS
4	ROCHESTER MEDICAL CORP. ONE ROCHESTER MEDICAL DR. STEWARTVILLE, MN 55976 US 507-533-9600 / 507-533-9600	ANTIBACTERIAL FOLEY CATHETER	ANTIBACTERIAL FOLEY CATHETER