FDA 510(k) Application Details - K041406

Device Classification Name Compressor, Air, Portable

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510(K) Number K041406
Device Name Compressor, Air, Portable
Applicant NEWPORT MEDICAL INSTRUMENTS
760 W 16TH STREET, BLDG. N
COSTA MESA, CA 92627 US
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Contact RICHARD WATERS
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Regulation Number 868.6250

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Classification Product Code BTI
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Date Received 05/26/2004
Decision Date 12/15/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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