510(k) K171165
- Device
- SmartByte Device
- Applicant
- Scientific Intake
- 510(k) number
- K171165
- Product code
- ONY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-05-18
- Date received
- 2017-04-20
- Regulation
- 876.5981
- Classification name
- Oral Removable Retainer For Weight Management
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Marc Gibeley
- Address
- 280 Merrimack St. Suite 503 Lawrence MA US 01843 01843
Source Documents#
Other 510(k) Records For Product Code ONY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN150033 | Sensor Monitored Alimentary Restriction Therapy (SMART) Device | Scientific Intake | 2016-09-26 |
Legacy Summary#
summary
FDA Review#
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