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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 K854331
Device Name MICRO-AIRE OTO/NEURO 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
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