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510(k) K101482

EM-9000 by Elite Medical, Inc. — Product Code LNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2011
Date Received
May 28, 2010
Clearance Type
Traditional
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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