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510(k) K123038

SWISS LITHOBREAKER by E.M.S Electro Medical Systems S.A — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2013
Date Received
September 28, 2012
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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