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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bur, surgical, general & plastic surgery
510(k) Number K894438
Device Name MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS
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 Number878.4820
Classification Product Code
GFF  
Date Received07/17/1989
Decision Date 08/21/1989
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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