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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 K152134
Device Name Reprocessed Vessel Sealer
Applicant
Sterilmed, Inc.
5010 Cheshire Pkwy.
Suite 2
Plymouth,  MN  55446
Applicant Contact PATRICIA KAUFMAN
Correspondent
Libra Medical
8401 73rd Ave. N.
Suite 63
Minneapolis,  MN  55428
Correspondent Contact MING CHENG CHEW
Regulation Number878.4400
Classification Product Code
NUJ  
Date Received07/31/2015
Decision Date 01/15/2016
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
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