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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 K873472
Device Name MEMBRANE HUMIDIFIER
Applicant
RESPIRATORY SUPPORT PRODUCTS, INC.
3183-D AIRWAY AVE.
COSTA MESA,  CA  92626
Applicant Contact ANTHONY V BERAN
Correspondent
RESPIRATORY SUPPORT PRODUCTS, INC.
3183-D AIRWAY AVE.
COSTA MESA,  CA  92626
Correspondent Contact ANTHONY V BERAN
Regulation Number868.5450
Classification Product Code
BTT  
Date Received08/28/1987
Decision Date 01/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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