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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 K050882
Device Name NEWDEAL ANKLE NAIL
Applicant
NEWDEAL S.A.
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Applicant Contact JUDITH E O'GRADY
Correspondent
NEWDEAL S.A.
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Correspondent Contact JUDITH E O'GRADY
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/07/2005
Decision Date 05/27/2005
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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