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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Incontinence, Urosheath Type, Sterile
510(k) Number K946243
Device Name CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER
Applicant
COLOPLAST A/S
1955 WEST OAK CIRCLE
MARIETTA,  GA  30062 -2249
Correspondent
COLOPLAST A/S
1955 WEST OAK CIRCLE
MARIETTA,  GA  30062 -2249
Regulation Number876.5250
Classification Product Code
EXJ  
Date Received12/22/1994
Decision Date 02/13/1995
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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