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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K870138
Device Name 1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE
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 Number868.5870
Classification Product Code
CBP  
Date Received01/13/1987
Decision Date 03/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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