510(k) K111179
- Device
- ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN
- Applicant
- SIESTA MEDICAL, INC.
- 510(k) number
- K111179
- Product code
- ORY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-07-01
- Date received
- 2011-04-27
- Regulation
- 872.5570
- Classification name
- Prelude Tongue Suspension System
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL KOLBER
- Address
- 101 Church St., Suite 3 Los Gatos CA US 95030 95030
FDA Registration Numbers#
- 3008792120
- 3013564228
- 2024311
- 2950160
Source Documents#
Other 510(k) Records For Product Code ORY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213159 | Encore System | Siesta Medical, Inc. | 2021-12-22 |
| K201238 | Encore System | Siesta Medical, Inc. | 2020-10-02 |
| K183310 | Encore System | Siesta Medical, Inc. | 2019-05-09 |
| K133680 | ENCORE SYSTEM | Siesta Medical, Inc. | 2014-03-26 |
| K121440 | ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT | Siesta Medical, Inc. | 2012-12-06 |
| K121814 | ENCORE TONGUE SUSPENSION SYSTEM | Siesta Medical, Inc. | 2012-11-07 |
| K110127 | PRELUDE III TONGUE SUSPENSION SYSTEM | Siesta Medical, Inc. | 2011-04-08 |
| K103179 | PRELUDE II TOUNGE SUSPENSION SYSTEM | Siesta Medical, Inc. | 2010-12-20 |
| K101060 | SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM | Siesta Medical, Inc. | 2010-07-08 |
Legacy Summary#
summary
FDA Review#
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