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FDA 510(k) Application Details - K140631
Device Classification Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
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510(K) Number
K140631
Device Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant
SHASER, INC.
10 Maguire Rd Ste 120
Lexington, MA 02421 US
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Contact
ANTHONY BURNS
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
ONF
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More FDA Info for this Product Code
Date Received
03/12/2014
Decision Date
05/16/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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