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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K853071
Device Name MEDIX ELECTRONIC NEBULIZING SYSTEM
Applicant
MEDIX CORP.
MEDIX HOUSE, CATHORPE
LUTTERWORTH, LEICS
LE17 6DB, ENGLAND,  GB
Applicant Contact PHILIP G STIMPSON
Correspondent
MEDIX CORP.
MEDIX HOUSE, CATHORPE
LUTTERWORTH, LEICS
LE17 6DB, ENGLAND,  GB
Correspondent Contact PHILIP G STIMPSON
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received07/23/1985
Decision Date 08/29/1985
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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