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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K931652
Device Name ACE 6.5 MM BONE SCREW
Applicant
Ace Medical Co.
14105 S. Avalon Blvd.
Los Angeles,  CA  90061
Applicant Contact JANICE FILIPPELLI
Correspondent
Ace Medical Co.
14105 S. Avalon Blvd.
Los Angeles,  CA  90061
Correspondent Contact JANICE FILIPPELLI
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/05/1993
Decision Date 04/28/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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