FDA 510(k) Application Details - K173214

Device Classification Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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510(K) Number K173214
Device Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant Northeast Scientific, Inc. (NES)
2142 Thomaston Avenue
Waterbury, CT 06704 US
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Contact Matthew Farley
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Regulation Number 878.4400

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Classification Product Code NUJ
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Date Received 10/02/2017
Decision Date 03/27/2018
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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