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FDA 510(k) Application Details - K163655
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K163655
Device Name
Powered Laser Surgical Instrument
Applicant
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd
2F, Building 3, Lane 561, Nujiang Road (North),
Shanghai CN
Other 510(k) Applications for this Company
Contact
Amy Lee
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/23/2016
Decision Date
03/17/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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