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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K880979
Device Name MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM
Applicant
MARQUEST MEDICAL PRODUCTS, INC.
11039 EAST LANSING CIR.
ENGLEWOOD,  CO  80112
Applicant Contact JOHN G ADAMS
Correspondent
MARQUEST MEDICAL PRODUCTS, INC.
11039 EAST LANSING CIR.
ENGLEWOOD,  CO  80112
Correspondent Contact JOHN G ADAMS
Regulation Number868.5450
Classification Product Code
BTT  
Date Received03/08/1988
Decision Date 07/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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