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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 K093914
Device Name NEWDEAL COMPRESSION PLATES
Applicant
Newdeal Sas
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact STEPHEN BEIER
Correspondent
Newdeal Sas
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact STEPHEN BEIER
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/22/2009
Decision Date 04/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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