The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corporation with the FDA for Telescope 0 O 10mm Wl 305mm / Telescope 30 O 10mm Wl 305mm / Telescope 50 O 10mm Wl 305mm, Telescope 0 O 10mm Wl 440mm / Telescope 30 O 10mm Wl 440mm / Telescope 50 O 10mm Wl 440mm.
| Device ID | K203226 |
| 510k Number | K203226 |
| Device Name: | TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM |
| Classification | Endoscope, Rigid |
| Applicant | Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061 |
| Contact | Michael Loiterman |
| Correspondent | Michael Loiterman Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061 |
| Product Code | GCM |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | HET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-02 |
| Decision Date | 2021-05-14 |