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510(k) K082701

URONIRS, MODEL 2000 by Urodynamix Technologies, Ltd. — Product Code FEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2008
Date Received
September 16, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Cystometric, Hydraulic
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

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