FDA 510(k) Application Details - K170170

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K170170
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Covidien llc
5920 Longbow Drive
Boulder, CO 80301 US
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Contact Sharon McDermott
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 01/19/2017
Decision Date 02/16/2017
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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