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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Nasal, Oxygen
510(k) Number K011125
Device Name NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
Applicant
HUDSON RESPIRATORY CARE, INC.
27711 DIAZ RD.
P.O. BOX 9020
TEMECULA,  CA  92589 -9020
Applicant Contact JEANNIE L DENNING
Correspondent
HUDSON RESPIRATORY CARE, INC.
27711 DIAZ RD.
P.O. BOX 9020
TEMECULA,  CA  92589 -9020
Correspondent Contact JEANNIE L DENNING
Regulation Number868.5340
Classification Product Code
CAT  
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
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