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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 K071560
Device Name PROVENT NASAL DILATOR, MODEL BR2
Applicant
Ventus Medical, Inc.
1171 Barroilhet Dr.
Hillsboroguh,  CA  94010
Applicant Contact CINDY DOMECUS
Correspondent
Ventus Medical, Inc.
1171 Barroilhet Dr.
Hillsboroguh,  CA  94010
Correspondent Contact CINDY DOMECUS
Regulation Number872.5570
Classification Product Code
OHP  
Date Received06/07/2007
Decision Date 02/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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