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FDA 510(k) Application Details - K982860
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K982860
Device Name
Powered Laser Surgical Instrument
Applicant
UNION MEDICAL ENGENEERING CO., LTD.
8930 S.W. 68TH COURT #H3
MIAMI, FL 33156 US
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Contact
ANNIE VALEZ
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
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More FDA Info for this Product Code
Date Received
08/13/1998
Decision Date
08/13/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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