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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 K070447
Device Name NEWDEAL COMPRESSION PLATE
Applicant
NEWDEAL SAS
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Applicant Contact JUDITH E O'GRADY
Correspondent
NEWDEAL SAS
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Correspondent Contact JUDITH E O'GRADY
Regulation Number888.3030
Classification Product Code
HRS  
Date Received02/15/2007
Decision Date 03/29/2007
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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