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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 K792382
Device Name STOMAHESIVE POWDER
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  
Date Received11/26/1979
Decision Date 12/20/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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