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FDA 510(k) Application Details - K100590
Device Classification Name
Powered Laser Surgical Instrument With Microbeam\Fractional Output
More FDA Info for this Device
510(K) Number
K100590
Device Name
Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant
JM SYSTEM CO., LTD.
410 DAERUNG TECHNO TOWN
8TH GASAN-DONG
GEUMCHEN-GU, SEOUL, 153-77 KR
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Contact
SU-GUN LEE
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
ONG
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More FDA Info for this Product Code
Date Received
03/02/2010
Decision Date
11/10/2010
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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