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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K890035
Device Name BACTERIA FILTER
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 Number868.5260
Classification Product Code
CAH  
Date Received01/04/1989
Decision Date 05/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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