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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 K021626
Device Name HALLU PLATES
Applicant
New Deal, S.A.
9109 Copenhaver Dr.
Potomac,  MD  20854
Applicant Contact NORMAN F ESTRIN
Correspondent
New Deal, S.A.
9109 Copenhaver Dr.
Potomac,  MD  20854
Correspondent Contact NORMAN F ESTRIN
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/17/2002
Decision Date 08/12/2002
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
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