FDA 510(k) Application Details - K981726

Device Classification Name Device, Positive Pressure Breathing, Intermittent

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510(K) Number K981726
Device Name Device, Positive Pressure Breathing, Intermittent
Applicant VORTRAN MEDICAL TECHNOLOGY 1, INC.
3941 J ST., SUITE 354
SACRAMENTO, CA 95819 US
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Contact GORDON A WONG
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Regulation Number 868.5905

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Classification Product Code NHJ
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Date Received 05/15/1998
Decision Date 09/17/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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