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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 K003626
Device Name DEVILBISS HUMIDIFIER
Applicant
SUNRISE MEDICAL HHG, INC.
100 DEVILBISS DR.
SOMERSET,  PA  15501
Applicant Contact ALLAN R JONES
Correspondent
SUNRISE MEDICAL HHG, INC.
100 DEVILBISS DR.
SOMERSET,  PA  15501
Correspondent Contact ALLAN R JONES
Regulation Number868.5450
Classification Product Code
BTT  
Date Received11/24/2000
Decision Date 05/04/2001
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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