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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, retention type, balloon
510(k) Number K941692
Device Name FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER
Applicant
ROCHESTER MEDICAL CORP.
1500 NW 2ND AVE.
P.O. BOX 188
STEWARTVILLE,  MN  55976
Applicant Contact RICHARD D FRYAR
Correspondent
ROCHESTER MEDICAL CORP.
1500 NW 2ND AVE.
P.O. BOX 188
STEWARTVILLE,  MN  55976
Correspondent Contact RICHARD D FRYAR
Regulation Number876.5130
Classification Product Code
EZL  
Subsequent Product Codes
GBM   KOD  
Date Received04/06/1994
Decision Date 03/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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