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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name blade, saw, surgical, cardiovascular
510(k) Number K850483
Device Name MICRO-AIRE STERNUM SAW REPLACEMENT BLADES
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 Number878.4820
Classification Product Code
DWH  
Date Received02/07/1985
Decision Date 03/01/1985
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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