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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nebulizer (direct patient interface)
510(k) Number K994352
Device Name SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896
Applicant
HUDSON RESPIRATORY CARE, INC.
27711 DIAZ RD.
P.O. BOX 9020
TEMECULA,  CA  92589 -9020
Applicant Contact JEANNIE DENNING
Correspondent
HUDSON RESPIRATORY CARE, INC.
27711 DIAZ RD.
P.O. BOX 9020
TEMECULA,  CA  92589 -9020
Correspondent Contact JEANNIE DENNING
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/23/1999
Decision Date 03/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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