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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K080983
Device Name PROVENT NASAL CANNULA
Applicant
VENTUS MEDICAL, INC.
1301 SHOREWAY ROAD
SUITE 340
BELMONT,  CA  94002
Applicant Contact CINDY DOMECUS
Correspondent
VENTUS MEDICAL, INC.
1301 SHOREWAY ROAD
SUITE 340
BELMONT,  CA  94002
Correspondent Contact CINDY DOMECUS
Regulation Number868.2375
Classification Product Code
MNR  
Date Received04/07/2008
Decision Date 08/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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