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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
510(k) Number K903713
Device Name OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229
Applicant
Micro-Aire Surgical Instruments, Inc.
24971 Ave. Stanford W.
Valencia,  CA  91355
Applicant Contact SIDDHARTH DESAI
Correspondent
Micro-Aire Surgical Instruments, Inc.
24971 Ave. Stanford W.
Valencia,  CA  91355
Correspondent Contact SIDDHARTH DESAI
Regulation Number878.4820
Classification Product Code
HSZ  
Date Received08/14/1990
Decision Date 09/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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