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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nail, fixation, bone
510(k) Number K072095
Device Name SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Applicant Contact JILL SHERMAN
Correspondent
SYNTHES (USA)
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Correspondent Contact JILL SHERMAN
Regulation Number888.3030
Classification Product Code
JDS  
Date Received07/31/2007
Decision Date 09/27/2007
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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