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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name heater, breathing system w/wo controller (not humidifier or nebulizer
510(k) Number K962220
Device Name HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
Applicant
MARQUEST MEDICAL PRODUCTS, INC.
11039 EAST LANSING CIR.
ENGLEWOOD,  CO  80112
Applicant Contact TOM DIELMANN
Correspondent
MARQUEST MEDICAL PRODUCTS, INC.
11039 EAST LANSING CIR.
ENGLEWOOD,  CO  80112
Correspondent Contact TOM DIELMANN
Regulation Number868.5270
Classification Product Code
BZE  
Date Received06/10/1996
Decision Date 01/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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