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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name collector, ostomy
510(k) Number K811240
Device Name SUR-FIT LOOP OSTOMY O.R. SET
Applicant
E. R. SQUIBB & SONS, INC.
40 W 57TH ST.
NEW YORK,  NY  10019
Correspondent
E. R. SQUIBB & SONS, INC.
40 W 57TH ST.
NEW YORK,  NY  10019
Regulation Number876.5900
Classification Product Code
EXB  
Subsequent Product Code
EZP  
Date Received05/04/1981
Decision Date 06/16/1981
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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