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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 Ste 2
Plymouth,  MN  55446
Applicant Contact PATRICIA KAUFMAN
Correspondent
LIBRA MEDICAL
8401 73RD AVE NORTH, SUITE 63
BROOKLYN PARK,  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
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