The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Vcare Dx.
| Device ID | K093556 |
| 510k Number | K093556 |
| Device Name: | VCARE DX |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
| Contact | Sarah Rizk |
| Correspondent | Sarah Rizk CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-17 |
| Decision Date | 2010-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405059827 | K093556 | 000 |