FDA 510(k) Application Details - K162802

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K162802
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant COVIDIEN LLC
15 HAMPSHIRE STREET
MANSFIELD, MA 02048 US
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Contact RACHEL SILVA
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 10/05/2016
Decision Date 01/24/2017
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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