FDA 510(k) Application Details - K182588

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

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510(K) Number K182588
Device Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant Surgical Instrument Service and Savings Inc (dba Medline ReN
1500 NE Hemlock Ave.
Redmond, OR 97756 US
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Contact Stephanie Boyle Mays
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Regulation Number 878.4400

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Classification Product Code NUJ
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Date Received 09/20/2018
Decision Date 10/31/2018
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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