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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 K950618
Device Name ACE SUPRACONDYLAR PLATE
Applicant
Ace Medical Co.
14105 S. Avalon Blvd.
Los Angeles,  CA  90061
Applicant Contact NANCY GIEZEN
Correspondent
Ace Medical Co.
14105 S. Avalon Blvd.
Los Angeles,  CA  90061
Correspondent Contact NANCY GIEZEN
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/10/1995
Decision Date 05/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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