FDA 510(k) Application Details - K143260

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

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510(K) Number K143260
Device Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant STERILMED, INC.
11400 73rd Ave N
Maple Grove, MN 55369 US
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Contact NICOLE BOSER
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Regulation Number 878.4400

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Classification Product Code NUJ
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Date Received 11/13/2014
Decision Date 02/23/2015
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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