The following data is part of a premarket notification filed by Scientific Intake with the FDA for Smartbyte Device.
| Device ID | K171165 |
| 510k Number | K171165 |
| Device Name: | SmartByte Device |
| Classification | Oral Removable Retainer For Weight Management |
| Applicant | Scientific Intake 280 Merrimack Street Suite 503 Lawrence, MA 01843 |
| Contact | Marc Gibeley |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 |
| Product Code | ONY |
| CFR Regulation Number | 876.5981 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-20 |
| Decision Date | 2017-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001615326 | K171165 | 000 |