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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 K112085
Device Name SYNTHES LCP PEDIATRIC PLATE SYSTEMS
Applicant
SYNTHES (USA) PRODUCTS LLC
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Applicant Contact ANGELA F LASSANDRO
Correspondent
SYNTHES (USA) PRODUCTS LLC
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Correspondent Contact ANGELA F LASSANDRO
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/21/2011
Decision Date 11/17/2011
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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