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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 K983853
Device Name DEPUY ACE TIMAX META PLATE
Applicant
Depuy Ace Medical Co.
2260 E. El Segundo Blvd.
El Segundo,  CA  90245
Applicant Contact KATHLEEN DRAGOVICH
Correspondent
Depuy Ace Medical Co.
2260 E. El Segundo Blvd.
El Segundo,  CA  90245
Correspondent Contact KATHLEEN DRAGOVICH
Regulation Number888.3030
Classification Product Code
HRS  
Date Received10/30/1998
Decision Date 12/22/1998
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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