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FDA 510(k) Application Details - K141237
Device Classification Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
More FDA Info for this Device
510(K) Number
K141237
Device Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant
ALMA INC.
26 REBECCA CT.
HOMOSASSA, FL 34446 US
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Contact
KATHY MAYNOR
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
ONF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/13/2014
Decision Date
03/13/2015
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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