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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 K901301
Device Name STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
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 Number868.5630
Classification Product Code
CAF  
Date Received03/20/1990
Decision Date 05/31/1990
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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