FDA 510(k) Application Details - K162751

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

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510(K) Number K162751
Device Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant Surgical Instrument Services and Savings, Inc
2747 SW 6th St.
Redmond, OR 97756 US
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Contact Brandi J Panteleon
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Regulation Number 878.4400

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Classification Product Code NUJ
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Date Received 09/30/2016
Decision Date 05/01/2017
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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