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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rod, fixation, intramedullary and accessories
510(k) Number K103002
Device Name SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Applicant Contact KARL J NITTINGER
Correspondent
SYNTHES (USA)
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Correspondent Contact KARL J NITTINGER
Regulation Number888.3020
Classification Product Code
HSB  
Date Received10/08/2010
Decision Date 03/02/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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