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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 K946165
Device Name CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM
Applicant
Elekta Instruments, Inc.
8 Executive Park W.
Atlanta,  GA  30329
Applicant Contact THOMAS PARKER
Correspondent
Elekta Instruments, Inc.
8 Executive Park W.
Atlanta,  GA  30329
Correspondent Contact THOMAS PARKER
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/19/1994
Decision Date 05/23/1995
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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