The following data is part of a premarket notification filed by Rovers Medical Devices B.v. with the FDA for Cervex-brush Combi.
| Device ID | K043369 |
| 510k Number | K043369 |
| Device Name: | CERVEX-BRUSH COMBI |
| Classification | Spatula, Cervical, Cytological |
| Applicant | ROVERS MEDICAL DEVICES B.V. LEKSTRAAT 10 Oss, NL 5347 Kv |
| Contact | Ir. M.d. Zwart |
| Correspondent | Ir. M.d. Zwart ROVERS MEDICAL DEVICES B.V. LEKSTRAAT 10 Oss, NL 5347 Kv |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-08 |
| Decision Date | 2005-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613647000601 | K043369 | 000 |
| 08719189246476 | K043369 | 000 |
| 08719189246070 | K043369 | 000 |
| 08719189246155 | K043369 | 000 |
| 08719189246186 | K043369 | 000 |
| 08719189246384 | K043369 | 000 |
| 10382904905269 | K043369 | 000 |
| 87191892460870 | K043369 | 000 |
| 87191892461556 | K043369 | 000 |
| 87191892461938 | K043369 | 000 |
| 28719189246081 | K043369 | 000 |