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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
2747 SW 6th St.
Redmond,  OR  97756
Applicant Contact BRANDI J. PANTELEON
Correspondent
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
2747 SW 6th St.
Redmond,  OR  97756
Correspondent Contact BRANDI J. PANTELEON
Regulation Number878.4400
Classification Product Code
NUJ  
Date Received12/29/2015
Decision Date 05/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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