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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 K914998
Device Name MICROAIRE(R) FACIAL BONE PLATING SYSTEM
Applicant
Micro Surgical Instruments Corp.
24971 Ave. Stanford W.
Valencia,  CA  91355
Applicant Contact MOE KHOSRAVI
Correspondent
Micro Surgical Instruments Corp.
24971 Ave. Stanford W.
Valencia,  CA  91355
Correspondent Contact MOE KHOSRAVI
Regulation Number888.3030
Classification Product Code
HRS  
Date Received11/07/1991
Decision Date 06/02/1992
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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