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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 K902168
Device Name ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)
Applicant
Micro-Aire Surgical Instruments, Inc.
24971 Ave. Stanford W.
Valencia,  CA  91355
Applicant Contact FRANS LIMONTA
Correspondent
Micro-Aire Surgical Instruments, Inc.
24971 Ave. Stanford W.
Valencia,  CA  91355
Correspondent Contact FRANS LIMONTA
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/15/1990
Decision Date 06/20/1990
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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