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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 K971992
Device Name UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)
Applicant
UROMED CORP.
64 A ST.
NEEDHAM,  MA  02194
Applicant Contact NANCY MACDONALD
Correspondent
UROMED CORP.
64 A ST.
NEEDHAM,  MA  02194
Correspondent Contact NANCY MACDONALD
Regulation Number876.5160
Classification Product Code
FHA  
Date Received05/29/1997
Decision Date 08/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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