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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clamp, penile
510(k) Number K885323
Device Name DACOMED EXTERNAL MALE CONTINENCE DEVICE
Applicant
DACOMED CORP.
1701 E. 79TH ST., STE. 17
MINNEAPOLIS,  MN  55425
Applicant Contact MARY M WILEN
Correspondent
DACOMED CORP.
1701 E. 79TH ST., STE. 17
MINNEAPOLIS,  MN  55425
Correspondent Contact MARY M WILEN
Regulation Number876.5160
Classification Product Code
FHA  
Date Received12/28/1988
Decision Date 02/08/1989
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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