ANTIBACTERIAL FOLEY CATHETER MANUFACTURED BY ROCHESTER MEDICAL CORP.

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Request for Information Form	Contact Information
Company Name	ROCHESTER MEDICAL CORP.
Address	ONE ROCHESTER MEDICAL DR.
City, State, Zip	STEWARTVILLE, MN 55976
Country	US
FDA Owner/Operator Phone	507-533-9600
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	ANTIBACTERIAL FOLEY CATHETER
FDA Proprietary Device Name	ANTIBACTERIAL FOLEY CATHETER
FDA Owner / Operator Number	9000289
FDA Owner / Operator Name	ROCHESTER MEDICAL CORP.
FDA Establishment Registration Number	2130787
FDA Registered Establishment Name	ROCHESTER MEDICAL CORP.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	09-30-03
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	C.R. BARD, INC. 428 POWERHOUSE RD. MONCKS CORNER, SC 29461 US 908-277-8000 / 908-277-8513	BARDEX I.C.	VARIOUS
2	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
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	SEWOON MEDICAL CO., LTD. 344-14, DORIM-RI, IPJANG-MYEON CHEONAN-SI, CHUNGCHEONGNAM-DO SEOUL, 330-822 KS 82-41-58429036 / 303-838-2407	3T/SEWOON SILICONE FOLEY BALLOON CATHETERS	ALL SILICONE FOLEY BALLOON CATHETER WITH AND WITH OUT TEMPERATURE SENSOR