The following data is part of a premarket notification filed by Siesta Medical, Inc. with the FDA for Prelude Ii Tounge Suspension System.
| Device ID | K103179 |
| 510k Number | K103179 |
| Device Name: | PRELUDE II TOUNGE SUSPENSION SYSTEM |
| Classification | Prelude Tongue Suspension System |
| Applicant | SIESTA MEDICAL, INC. 101 CHURCH STREET SUITE 3 Los Gatos, CA 95030 |
| Contact | Michael Kolber |
| Correspondent | Michael Kolber SIESTA MEDICAL, INC. 101 CHURCH STREET SUITE 3 Los Gatos, CA 95030 |
| Product Code | ORY |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-28 |
| Decision Date | 2010-12-20 |
| Summary: | summary |