The following data is part of a premarket notification filed by Millenium Dental Laboratory, Inc with the FDA for Millenium Anti-snoring Device.
Device ID | K112627 |
510k Number | K112627 |
Device Name: | MILLENIUM ANTI-SNORING DEVICE |
Classification | Device, Jaw Repositioning |
Applicant | MILLENIUM DENTAL LABORATORY, INC 18056 WACO DRIVE NW Ramsey, MN 55303 |
Contact | Nghiep V Nguyen |
Correspondent | Nghiep V Nguyen MILLENIUM DENTAL LABORATORY, INC 18056 WACO DRIVE NW Ramsey, MN 55303 |
Product Code | LQZ |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-09 |
Decision Date | 2012-06-06 |