The following data is part of a premarket notification filed by Cit Ortho with the FDA for C Scope Visualization System.
| Device ID | K203526 |
| 510k Number | K203526 |
| Device Name: | C Scope Visualization System |
| Classification | Arthroscope |
| Applicant | CIT Ortho 26202 Detroit Road Ste 340 Westlake, OH 44145 |
| Contact | Megan Lecavalier |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-12-02 |
| Decision Date | 2021-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850009724001 | K203526 | 000 |
| 00850009724038 | K203526 | 000 |
| 00850009724021 | K203526 | 000 |