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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, Biodegradable, Soft Tissue
510(k) Number K092898
Device Name CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
Applicant
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773 -4908
Applicant Contact LORNA K LINVILLE
Correspondent
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773 -4908
Correspondent Contact LORNA K LINVILLE
Regulation Number888.3030
Classification Product Code
MAI  
Date Received09/21/2009
Decision Date 10/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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