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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 K903664
Device Name MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
Applicant
MICRO-AIRE SURGICAL INSTRUMENTS, INC.
24971 AVENUE STANFORD WEST
VALENCIA,  CA  91355
Applicant Contact SIDDHARTH DESAI
Correspondent
MICRO-AIRE SURGICAL INSTRUMENTS, INC.
24971 AVENUE STANFORD WEST
VALENCIA,  CA  91355
Correspondent Contact SIDDHARTH DESAI
Regulation Number882.4310
Classification Product Code
HBE  
Date Received08/14/1990
Decision Date 09/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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