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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 K960397
Device Name MEDICATOR AEROSOL DRUG DELIVERY SYSTEM
Applicant
HEALTHLINE MEDICAL
4610 LITTLEJOHN ST.
BALDWIN PARK,  CA  91706
Applicant Contact RUSSELL W KING
Correspondent
HEALTHLINE MEDICAL
4610 LITTLEJOHN ST.
BALDWIN PARK,  CA  91706
Correspondent Contact RUSSELL W KING
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/29/1996
Decision Date 04/26/1996
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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