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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K854332
Device Name MICRO-AIRE STAPES DRILL SYSTEM
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 Number874.4250
Classification Product Code
ERL  
Date Received10/28/1985
Decision Date 01/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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