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510(k) K132672

EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER by Dornier Medtech America — Product Code LNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2013
Date Received
August 27, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Extracorporeal Shock-Wave, Urological
Device Class
Class II
Regulation Number
876.5990
Review Panel
GU
Submission Type

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