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 DRIVE |
HILLSBOROUGH,
CA
94010
|
|
Applicant Contact |
CINDY DOMECUS |
Correspondent |
VENTUS MEDICAL, INC. |
1171 BARROILHET DRIVE |
HILLSBOROUGH,
CA
94010
|
|
Correspondent Contact |
CINDY DOMECUS |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 06/07/2007 |
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
|
|
|