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510(k) K970465

BOUSER'S URINAL by General Polymers — Product Code EXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1997
Date Received
February 7, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Incontinence, Urosheath Type, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

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