The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Crystalview Pro Irrigation Console, Crystalview Pro Autoclavable Remote Control.
| Device ID | K182882 |
| 510k Number | K182882 |
| Device Name: | CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control |
| Classification | Arthroscope |
| Applicant | Conmed Corporation 525 French Road Utica, NY 13502 |
| Contact | Orjada Dervishleri |
| Correspondent | Orjada Dervishleri Conmed Corporation 525 French Road Utica, NY 13502 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-15 |
| Decision Date | 2018-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10845854850381 | K182882 | 000 |
| 10845854648506 | K182882 | 000 |
| 10653405987505 | K182882 | 000 |
| 30845854648517 | K182882 | 000 |