FDA 510(k) Application Details - K955591

Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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510(K) Number K955591
Device Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Applicant MICROAIRE SURGICAL INSTRUMENTS, INC.
1641 EDLICH DR.
CHARLOTTESVILLE, VA 22911 US
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Contact MIKE FARD
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Regulation Number 878.4820

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Classification Product Code HWE
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Date Received 12/07/1995
Decision Date 01/18/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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