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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, polyethylene
510(k) Number K040232
Device Name LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999
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 Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
HCF  
Date Received02/02/2004
Decision Date 03/01/2004
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
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