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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 K092247
Device Name SYNTHES LOCKING HAND PLATES
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Applicant Contact SHERI L MUSGNUNG
Correspondent
SYNTHES (USA)
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Correspondent Contact SHERI L MUSGNUNG
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/28/2009
Decision Date 09/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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