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FDA 510(k) Application Details - K992482
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K992482
Device Name
Powered Laser Surgical Instrument
Applicant
RADIANCY, LTD.
555 13TH ST. NW
WASHINGTON, DC 20004 US
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Contact
JONATHAN S KAHAN
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
07/26/1999
Decision Date
12/27/1999
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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