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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K955104
Device Name HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
Applicant
AUTOMATIC LIQUID PACKAGING, INC.
2200 W. LAKE SHORE DR.
WOODSTOCK,  IL  60098
Applicant Contact JOHN BRDA
Correspondent
AUTOMATIC LIQUID PACKAGING, INC.
2200 W. LAKE SHORE DR.
WOODSTOCK,  IL  60098
Correspondent Contact JOHN BRDA
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/08/1995
Decision Date 06/11/1996
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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