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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 K102339
Device Name CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE
Applicant
CONMED LINVATEC
11311 CONCEPT BOULEVARD
LARGO,  FL  33773 -4908
Applicant Contact JAN FLEGEAU
Correspondent
CONMED LINVATEC
11311 CONCEPT BOULEVARD
LARGO,  FL  33773 -4908
Correspondent Contact JAN FLEGEAU
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
MBI  
Date Received08/18/2010
Decision Date 11/23/2010
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
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