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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K871157
Device Name C.P.A.P. NASAL CANNULA
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 Number868.5905
Classification Product Code
BZD  
Date Received03/24/1987
Decision Date 04/21/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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