FDA 510(k) Application Details - K973268

Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)

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510(K) Number K973268
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant MICROAIRE SURGICAL INSTRUMENTS, INC.
1641 EDLICH DR.
CHARLOTTESVILLE, VA 22911 US
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Contact CCARL ANGLES
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Regulation Number 878.4780

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Classification Product Code BTA
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Date Received 08/29/1997
Decision Date 11/26/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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