FDA 510(k) Application Details - K160290

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K160290
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Covidien LLC
5920 LONGBOW DRIVE
BOULDER, CO 80301 US
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Contact Nancy Sauer
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 02/03/2016
Decision Date 05/19/2016
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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