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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 K851678
Device Name OSTOMY BAGS URETHEROSTOMY
Applicant
DBT MEDICAL LTD.
14 EAGLE INDUSTRIAL ESTATE
WITNEY,0X8 7AZ,  GB
Applicant Contact BLACKBURN
Correspondent
DBT MEDICAL LTD.
14 EAGLE INDUSTRIAL ESTATE
WITNEY,0X8 7AZ,  GB
Correspondent Contact BLACKBURN
Regulation Number876.5900
Classification Product Code
EXB  
Date Received04/23/1985
Decision Date 06/27/1985
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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