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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 K981775
Device Name DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE
Applicant
Depuy Ace Medical Co.
2260 E. El Segundo Blvd.
El Segundo,  CA  90245
Applicant Contact PAUL DONER
Correspondent
Depuy Ace Medical Co.
2260 E. El Segundo Blvd.
El Segundo,  CA  90245
Correspondent Contact PAUL DONER
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/20/1998
Decision Date 07/29/1998
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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