The following data is part of a premarket notification filed by Siesta Medical, Inc. with the FDA for Siesta Medical, Inc., Prelude Tongue Suspension System.
| Device ID | K101060 |
| 510k Number | K101060 |
| Device Name: | SIESTA MEDICAL, INC., PRELUDE TONGUE 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-15 |
| Decision Date | 2010-07-08 |
| Summary: | summary |