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510(k) K092033

VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR by Elmed USA — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2010
Date Received
July 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Electro-Hydraulic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type

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