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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 K920738
Device Name ACE 100 DEGREES TUBULAR PLATE
Applicant
ACE ORTHOPEDIC MANUFACTURING CO.
14105 SOUTH AVALON BLVD.
LOS ANGELES,  CA  90061
Applicant Contact JANICE L FILIPPELLI
Correspondent
ACE ORTHOPEDIC MANUFACTURING CO.
14105 SOUTH AVALON BLVD.
LOS ANGELES,  CA  90061
Correspondent Contact JANICE L FILIPPELLI
Regulation Number888.3030
Classification Product Code
HRS  
Date Received02/19/1992
Decision Date 07/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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