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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 K102404
Device Name PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
Applicant
VENTUS MEDICAL, INC.
1301 SHOREWAY ROAD
SUITE 425
belmont,  CA  94002
Applicant Contact michael nevares
Correspondent
VENTUS MEDICAL, INC.
1301 SHOREWAY ROAD
SUITE 425
belmont,  CA  94002
Correspondent Contact michael nevares
Regulation Number872.5570
Classification Product Code
OHP  
Date Received08/24/2010
Decision Date 12/02/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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