Device Classification Name |
Dilator, Nasal
|
510(k) Number |
K120665 |
Device Name |
INVENT SNORING DEVICE |
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 | 874.3900
|
Classification Product Code |
|
Date Received | 03/05/2012 |
Decision Date | 06/12/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|