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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 K851940
Device Name STERILE WATER FOR INHALATION USP 2D0799
Applicant
TRAVENOL LABORATORIES, S.A.
DEERFIELD,  IL  60015
Applicant Contact DENNIS A OCWIEJA
Correspondent
TRAVENOL LABORATORIES, S.A.
DEERFIELD,  IL  60015
Correspondent Contact DENNIS A OCWIEJA
Regulation Number868.5450
Classification Product Code
BTT  
Date Received05/03/1985
Decision Date 06/20/1985
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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