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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 K160333
Device Name Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider
Applicant
Surgical Instrument Service and Savings, Inc.
2747 SW 6th St.
Redmond,  OR  97756
Applicant Contact BRANDI J. PANTELEON
Correspondent
Surgical Instrument Service and Savings, Inc.
2747 SW 6th St.
Redmond,  OR  97756
Correspondent Contact BRANDI J. PANTELEON
Regulation Number878.4400
Classification Product Code
NUJ  
Date Received02/08/2016
Decision Date 07/20/2016
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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