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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K031443
Device Name LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS
Applicant
Lsi Solutions
7796 Victor-Mendon Rd.
Victor,  NY  14564
Applicant Contact CHRISTOPHER A KLACZYK
Correspondent
Lsi Solutions
7796 Victor-Mendon Rd.
Victor,  NY  14564
Correspondent Contact CHRISTOPHER A KLACZYK
Regulation Number878.4840
Classification Product Code
NEW  
Subsequent Product Codes
GAM   GAS   GAW  
Date Received05/06/2003
Decision Date 06/18/2003
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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