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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, Polyester
510(k) Number K203120
Device Name RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
Applicant
Lsi Solutions, Inc.
7796 Victor-Mendon Rd.
Victor,  NY  14589
Applicant Contact Christopher B Miller
Correspondent
Lsi Solutions, Inc.
7796 Victor-Mendon Rd.
Victor,  NY  14589
Correspondent Contact Christopher B Miller
Regulation Number878.5000
Classification Product Code
GAS  
Subsequent Product Code
GAW  
Date Received10/16/2020
Decision Date 11/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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