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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 K895231
Device Name CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
Applicant
HUDSON OXYGEN THERAPY SALES CO.
27711 DIAZ ST.
P.O. BOX 66
TEMECULA,  CA  92390
Applicant Contact JORGE HAIDER
Correspondent
HUDSON OXYGEN THERAPY SALES CO.
27711 DIAZ ST.
P.O. BOX 66
TEMECULA,  CA  92390
Correspondent Contact JORGE HAIDER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/22/1989
Decision Date 10/27/1989
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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