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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 K871618
Device Name PREFILLED STERILE WATER FOR INHALATION, USP
Applicant
AUTOMATIC LIQUID PACKAGING, INC.
2200 W. LAKE SHORE DR.
WOODSTOCK,  IL  60098
Applicant Contact FRANK LEO
Correspondent
AUTOMATIC LIQUID PACKAGING, INC.
2200 W. LAKE SHORE DR.
WOODSTOCK,  IL  60098
Correspondent Contact FRANK LEO
Regulation Number868.5450
Classification Product Code
BTT  
Date Received04/27/1987
Decision Date 05/08/1987
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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