510(k) DEN150033
- Device
- Sensor Monitored Alimentary Restriction Therapy (SMART) Device
- Applicant
- Scientific Intake
- 510(k) number
- DEN150033
- Product code
- ONY
- Decision
- Unknown (DENG)
- Decision date
- 2016-09-26
- Date received
- 2015-07-31
- Regulation
- 876.5981
- Classification name
- Oral Removable Retainer For Weight Management
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- William Longley
- Address
- 2859 Paces Ferry Rd., Suite 1710 Atlanta GA US 30339 30339
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ONY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171165 | SmartByte Device | Scientific Intake | 2017-05-18 |