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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K111779
Device Name Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
Applicant
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773 -4908
Applicant Contact JOHN CUSACK
Correspondent
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773 -4908
Correspondent Contact JOHN CUSACK
Regulation Number888.3040
Classification Product Code
MBI  
Date Received06/24/2011
Decision Date 08/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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