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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 K101536
Device Name 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM
Applicant
SYNTHES (USA) LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact LISA GRANEY
Correspondent
SYNTHES (USA) LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact LISA GRANEY
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/03/2010
Decision Date 09/15/2010
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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