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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 K862852
Device Name MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR
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
GFF  
Date Received07/29/1986
Decision Date 08/11/1986
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
Predetermined Change
Control Plan Authorized		 No
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