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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sheath, corrugated rubber, for nonindwelling catheter, sterile
510(k) Number K883119
Device Name VPI NON-ADHESIVE CONDOM CATHETER
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact SUE SMITH
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact SUE SMITH
Regulation Number876.5250
Classification Product Code
EYT  
Date Received07/25/1988
Decision Date 08/02/1988
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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