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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 K100593
Device Name SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME
Applicant
Lsi Solutions, Inc.
7796 Victor-Mendon Rd.
Victor,  NY  14564
Applicant Contact PETER SPATH
Correspondent
Lsi Solutions, Inc.
7796 Victor-Mendon Rd.
Victor,  NY  14564
Correspondent Contact PETER SPATH
Regulation Number878.5010
Classification Product Code
GAW  
Subsequent Product Codes
GAS   GCJ   HCF  
Date Received03/02/2010
Decision Date 10/13/2010
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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