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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 K970465
Device Name BOUSER'S URINAL
Applicant
General Polymers
55 Northern Blvd.
Suite 410
Great Neck,  NY  10012
Applicant Contact MILTON N BENEKE JR.
Correspondent
General Polymers
55 Northern Blvd.
Suite 410
Great Neck,  NY  10012
Correspondent Contact MILTON N BENEKE JR.
Regulation Number876.5250
Classification Product Code
EXJ  
Date Received02/07/1997
Decision Date 12/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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