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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clamp, penile
510(k) Number K974040
Device Name C3 EXTERNAL MALE BLADDER CONTROL DEVICE
Applicant
TIMM RESEARCH CO.
6541 CITY WEST PKWY.
EDEN PRAIRIE,  MN  55344
Applicant Contact DAVID ANDERSON
Correspondent
TIMM RESEARCH CO.
6541 CITY WEST PKWY.
EDEN PRAIRIE,  MN  55344
Correspondent Contact DAVID ANDERSON
Regulation Number876.5160
Classification Product Code
FHA  
Date Received10/24/1997
Decision Date 07/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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