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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 K120807
Device Name SYNTHES MULTILOC HUMERAL NAILING SYSTEM
Applicant
Synthes USA Products, LLC
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact REBECCA BLANK
Correspondent
Synthes USA Products, LLC
1301 Goshen Pkwy.
19380,  PA  19380
Correspondent Contact REBECCA BLANK
Regulation Number888.3020
Classification Product Code
HSB  
Date Received03/16/2012
Decision Date 07/06/2012
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
Recalls CDRH Recalls
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