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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bag, intestine
510(k) Number K910914
Device Name SURGICAL TISSUE POUCH
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 Number878.4100
Classification Product Code
KGY  
Date Received03/05/1991
Decision Date 03/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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