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510(k) K971913

GR100F URINE FLOWMETER by Albyn Medical , Ltd. — Product Code EXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1997
Date Received
May 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Uroflowmeter
Device Class
Class II
Regulation Number
876.1800
Review Panel
GU
Submission Type

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