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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(k) Number K905097
Device Name MICRO-AIRE MODEL NUMBER: MK-426
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 Number882.4310
Classification Product Code
HBE  
Date Received11/13/1990
Decision Date 12/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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