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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene
510(k) Number K160529
Device Name Pledgeted COR-SUTURE QUICK LOAD
Applicant
Lsi Soultions
7796 Victor-Mendon Rd.
Victor,  NY  14564
Applicant Contact KEVIN BENTLEY
Correspondent
Lsi Soultions
7796 Victor-Mendon Rd.
Victor,  NY  14564
Correspondent Contact KEVIN BENTLEY
Regulation Number878.5010
Classification Product Code
GAW  
Subsequent Product Code
GAS  
Date Received02/25/2016
Decision Date 09/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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