The following data is part of a premarket notification filed by Sunstar Suisse S.a. with the FDA for Grindcare System.
| Device ID | K163448 |
| 510k Number | K163448 |
| Device Name: | GrindCare System |
| Classification | Device, Biofeedback |
| Applicant | SUNSTAR SUISSE S.A. Route De Pallatex 11 Etoy, CH 1163 |
| Contact | Olivier Ducamp |
| Correspondent | Calley Herzog Biologics Consulting 400 N. Washington St. Suite 100 Alexandria, VA 22314 |
| Product Code | HCC |
| Subsequent Product Code | KZM |
| Subsequent Product Code | NUW |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-08 |
| Decision Date | 2017-09-01 |
| Summary: | summary |