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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Pressure And Accessories
510(k) Number K011134
Device Name OXYGEN SUPPLY TUBING, MODEL 1115
Applicant
Hudson Respiratory Care, Inc.
27711 Diaz Rd.
P.O. Box 9020
Temecula,  CA  92589 -9020
Applicant Contact JEANNIE K DENNING
Correspondent
Hudson Respiratory Care, Inc.
27711 Diaz Rd.
P.O. Box 9020
Temecula,  CA  92589 -9020
Correspondent Contact JEANNIE K DENNING
Regulation Number868.5860
Classification Product Code
BYX  
Date Received04/13/2001
Decision Date 06/13/2001
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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