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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 WEST OAK CIR.
MARIETTA,  GA  30062 -2249
Applicant Contact M. SYDNEY LILLY
Correspondent
COLOPLAST CORP.
1955 WEST OAK CIR.
MARIETTA,  GA  30062 -2249
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
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