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FDA 510(k) Application Details - K152898
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K152898
Device Name
Powered Laser Surgical Instrument
Applicant
BEIJING SINCOHEREN SCIENCE AND TECH. DEVELOPMENT CO., LTD
ROOM 305, NO.43, XIZHIMEN NORTH STREET
HAIDIAN DISTRICT
BEIJING 100044 CN
Other 510(k) Applications for this Company
Contact
XIN WANG
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
10/01/2015
Decision Date
02/09/2016
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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