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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bag, Urine Collection, Leg, For External Use, Sterile
510(k) Number K955609
Device Name CONVEEN URINE BAG - STERILE
Applicant
Coloplast Corp.
1955 W. Oak Cir.
Marietta,  GA  30062
Applicant Contact M. SYDNEY LILLY
Correspondent
Coloplast Corp.
1955 W. Oak Cir.
Marietta,  GA  30062
Correspondent Contact M. SYDNEY LILLY
Regulation Number876.5250
Classification Product Code
FAQ  
Date Received12/08/1995
Decision Date 12/29/1995
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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