The following data is part of a premarket notification filed by Rovers Medical Devices B.v. with the FDA for Rovers Endocervex-brush.
| Device ID | K001119 |
| 510k Number | K001119 |
| Device Name: | ROVERS ENDOCERVEX-BRUSH |
| 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 | 2000-04-07 |
| Decision Date | 2000-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613647000625 | K001119 | 000 |
| 08719189246513 | K001119 | 000 |
| 28719189246296 | K001119 | 000 |
| 08719189246131 | K001119 | 000 |
| 08719189246308 | K001119 | 000 |
| 50649111303539 | K001119 | 000 |
| 87191892461174 | K001119 | 000 |
| 87191892461488 | K001119 | 000 |
| 00613647000618 | K001119 | 000 |
| 08719189246551 | K001119 | 000 |