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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K850597
Device Name MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL
Applicant
Micro-Aire Surgical Instruments, Inc.
505 Fourth St.
San Fernando,  CA  91340
Applicant Contact GERALD BROOKS
Correspondent
Micro-Aire Surgical Instruments, Inc.
505 Fourth St.
San Fernando,  CA  91340
Correspondent Contact GERALD BROOKS
Regulation Number872.4200
Classification Product Code
EFB  
Date Received02/15/1985
Decision Date 03/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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