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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K912108
Device Name BLADES, WHISKERS, TRIMMERS, CUTTERS, AND BURS
Applicant
Microaire Advanced Surgical Products
24907 Ave. Tibbetts
Unit A
Valencia,  CA  91355
Applicant Contact SIDDHARTH DESAI
Correspondent
Microaire Advanced Surgical Products
24907 Ave. Tibbetts
Unit A
Valencia,  CA  91355
Correspondent Contact SIDDHARTH DESAI
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/13/1991
Decision Date 07/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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