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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K895589
Device Name MANUAL RESUSCITATOR
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 Number868.5915
Classification Product Code
BTM  
Date Received09/15/1989
Decision Date 03/30/1990
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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