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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K122860
Device Name KLS MARTIN RECON TALON
Applicant
KLS Martin L.P.
11201 Saint Johns Industrial Pkwy. S.
Jacksonville,  FL  32246
Applicant Contact JENNIFER DAMATO
Correspondent
KLS Martin L.P.
11201 Saint Johns Industrial Pkwy. S.
Jacksonville,  FL  32246
Correspondent Contact JENNIFER DAMATO
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/18/2012
Decision Date 11/14/2012
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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