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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 K850750
Device Name DISPOSABLE UROSTOMY POUCH
Applicant
Biolog, Inc.
3447 Investment Blvd. Suite 3
Hayward,  CA  94545
Applicant Contact DON BARNBY
Correspondent
Biolog, Inc.
3447 Investment Blvd. Suite 3
Hayward,  CA  94545
Correspondent Contact DON BARNBY
Regulation Number876.5900
Classification Product Code
EXB  
Date Received02/25/1985
Decision Date 05/23/1985
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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