FDA 510(k) Application Details - K171752

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K171752
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Genicon, Inc
6869 Stapoint Court Suite 114
Winter Park, FL 32792 US
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Contact Katlyn Kachman
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 06/13/2017
Decision Date 10/17/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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