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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 K141796
Device Name DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
Applicant
SYNTHES (USA) PRODUCTS LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact KARA ELKIN
Correspondent
SYNTHES (USA) PRODUCTS LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact KARA ELKIN
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/03/2014
Decision Date 08/29/2014
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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