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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 K896160
Device Name WILLIAMS PENILE ANESTHETIC RETAINER
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact MICHELLE YOUNG
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact MICHELLE YOUNG
Regulation Number876.5160
Classification Product Code
FHA  
Date Received10/24/1989
Decision Date 02/16/1990
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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