The following data is part of a premarket notification filed by Ventus Medical, Inc. with the FDA for Invent Snoring Device.
Device ID | K120665 |
510k Number | K120665 |
Device Name: | INVENT SNORING DEVICE |
Classification | Dilator, Nasal |
Applicant | VENTUS MEDICAL, INC. 1171 BARROILHET DRIVE Hillsborough, CA 94010 |
Contact | Cindy Domecus |
Correspondent | Cindy Domecus VENTUS MEDICAL, INC. 1171 BARROILHET DRIVE Hillsborough, CA 94010 |
Product Code | LWF |
CFR Regulation Number | 874.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-03-05 |
Decision Date | 2012-06-12 |
Summary: | summary |