FDA 510(k) K153745, Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider, by Surgical Instrument Service and Savings Inc.(Dba Medline Ren
FDA 510(k) K153745, Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider, by Surgical Instrument Service and Savings Inc.(Dba Medline Ren
Device Classification Name: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
510(k) Number: K153745
Device Name: Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
Applicant: Surgical Instrument Service and Savings Inc.(Dba Medline Ren
Regulation Number: 878.4400
Classification Product Code: NUJ
Date Received: 12/29/2015
Decision Date: 05/02/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery
Total number of pages: 2,292
Fully redacted pages: 1,919
Content pages: 373
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