The following data is part of a premarket notification filed by Rovers Medical Devices B.v. with the FDA for Rovers Spatula.
| Device ID | K002520 |
| 510k Number | K002520 |
| Device Name: | ROVERS SPATULA |
| Classification | Spatula, Cervical, Cytological |
| Applicant | ROVERS MEDICAL DEVICES B.V. 960 CHAPEA RD. Pasadena, CA 91107 |
| Contact | Todd M Gates |
| Correspondent | Todd M Gates ROVERS MEDICAL DEVICES B.V. 960 CHAPEA RD. Pasadena, CA 91107 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-15 |
| Decision Date | 2000-11-13 |