FDA 510(k) Application Details - K011125

Device Classification Name Cannula, Nasal, Oxygen

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510(K) Number K011125
Device Name Cannula, Nasal, Oxygen
Applicant HUDSON RESPIRATORY CARE, INC.
27711 DIAZ RD.
P.O. BOX 9020
TEMECULA, CA 92589-9020 US
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Contact JEANNIE L DENNING
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Regulation Number 868.5340

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Classification Product Code CAT
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Date Received 04/13/2001
Decision Date 06/13/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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