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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 K883964
Device Name AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
Applicant
BAXTER HEALTHCARE CORP.
27200 NORTH TOURNEY RD.
P.O. BOX 5900
VALENCIA,  CA  91355 -8900
Applicant Contact A CAMPBELL
Correspondent
BAXTER HEALTHCARE CORP.
27200 NORTH TOURNEY RD.
P.O. BOX 5900
VALENCIA,  CA  91355 -8900
Correspondent Contact A CAMPBELL
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/20/1988
Decision Date 11/30/1988
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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