FDA 510(k) Application Details - K171262

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K171262
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Cynosure, Inc
5 Carlisle Road
Westford, MA 01886 US
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Contact Amy Tannenbaum
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 05/01/2017
Decision Date 09/22/2017
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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