FDA 510(k) Application Details - K962223

Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)

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510(K) Number K962223
Device Name Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant MARQUEST MEDICAL PRODUCTS, INC.
11039 EAST LANSING CIR.
ENGLEWOOD, CO 80112 US
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Contact TOM DIELMANN
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Regulation Number 868.5450

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Classification Product Code BTT
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Date Received 06/10/1996
Decision Date 01/14/1997
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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