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510(k) K131721

EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 by Comed Medical Systems Co., Ltd. — Product Code LNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2014
Date Received
June 12, 2013
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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