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FDA 510(k) Application Details - K123889
Device Classification Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
More FDA Info for this Device
510(K) Number
K123889
Device Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant
THERAVANT CORPORATION
131 Kelekent Lane
Cary, NC 27518 US
Other 510(k) Applications for this Company
Contact
Marcy Moore
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
ONF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/18/2012
Decision Date
03/04/2013
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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