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FDA 510(k) Application Details - K132266
Device Classification Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
More FDA Info for this Device
510(K) Number
K132266
Device Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant
SHASER, INC.
10 MAGUIRE RD STE 120
BUILDING ONE
LEXINGTON, MA 02421 US
Other 510(k) Applications for this Company
Contact
ANTHONY BURNS
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
07/22/2013
Decision Date
09/30/2013
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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