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510(k) Data Aggregation
K Number
K970465Device Name
BOUSER'S URINAL
Manufacturer
GENERAL POLYMERS
Date Cleared
1997-12-18
(314 days)
Product Code
EXJ
Regulation Number
876.5250Why did this record match?
Applicant Name (Manufacturer) :
GENERAL POLYMERS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To collect urine to provide assistance for male urinary incontinence. This device is intended for non-prescription use and it is re-usable after cleaning and washing. It is intended for non probanpuen ass annected to an indwelling catheter. This device is not designed for pediatric use.
Device Description
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