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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 K082541
Device Name HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM
Applicant
MEDI NUCLEAR CORP., INC.
4610 LITTLEJOHN ST.
BALDWIN PARK,  CA  91706
Applicant Contact JERRY SCHOEN
Correspondent
MEDI NUCLEAR CORP., INC.
4610 LITTLEJOHN ST.
BALDWIN PARK,  CA  91706
Correspondent Contact JERRY SCHOEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/02/2008
Decision Date 11/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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