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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pin, fixation, smooth
510(k) Number K142134
Device Name C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES
Applicant
CONMED CORPORATION, LARGO
11311 CONCEPT BLVD
LARGO,  FL  33773
Applicant Contact JOY LOVETT
Correspondent
CONMED CORPORATION, LARGO
11311 CONCEPT BLVD
LARGO,  FL  33773
Correspondent Contact JOY LOVETT
Regulation Number888.3040
Classification Product Code
HTY  
Date Received08/04/2014
Decision Date 09/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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