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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 K914772
Device Name MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001
Applicant
MEDIX CORP.
MEDIX HOUSE, CATHORPE
LUTTERWORTH, LEICS
LE17 6DB, ENGLAND,  GB
Applicant Contact PHILIP STIMPSON
Correspondent
MEDIX CORP.
MEDIX HOUSE, CATHORPE
LUTTERWORTH, LEICS
LE17 6DB, ENGLAND,  GB
Correspondent Contact PHILIP STIMPSON
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/16/1991
Decision Date 07/24/1992
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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