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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 K912206
Device Name MICRO-AIRE ARTHROS SURG BLADES-VARIOUS CO PROD NO.
Applicant
Microaire
24971 Ave. Stanford W.
Valencia,  CA  91355
Applicant Contact FRANS LIMONTA
Correspondent
Microaire
24971 Ave. Stanford W.
Valencia,  CA  91355
Correspondent Contact FRANS LIMONTA
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/20/1991
Decision Date 08/16/1991
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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