FDA 510(k) Application Details - K132170

Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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510(K) Number K132170
Device Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant SHASER, INC.
10 MAGUIRE ROAD
LEXINGTON, MA 02421 US
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Contact ANTHONY BURNS
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Regulation Number 878.4810

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Classification Product Code ONF
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Date Received 07/15/2013
Decision Date 11/26/2013
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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