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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name expiratory resistance valve, intranasal, for obstructive sleep apnea
510(k) Number K090398
Device Name PROVENT PROFESSIONAL SLEEP APNEA THERAPY
Applicant
VENTUS MEDICAL, INC.
1301 SHOREWAY ROAD
SUITE 425
BELMONT,  CA  94002
Applicant Contact MARY ROSE
Correspondent
VENTUS MEDICAL, INC.
1301 SHOREWAY ROAD
SUITE 425
BELMONT,  CA  94002
Correspondent Contact MARY ROSE
Regulation Number872.5570
Classification Product Code
OHP  
Date Received02/17/2009
Decision Date 04/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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