RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER


definition

Device Classification Name

catheter, urological (antimicrobial) and accessories

510(k) Number K001143
Device Name RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
Original Applicant
ROCHESTER MEDICAL CORP.
one rochester medical dr.
stewartville, 
MN 
55976

Original Contact mary wilen
Regulation Number 876.5130
Classification Product Code
MJC  
Date Received 04/10/2000
Decision Date 07/07/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No