The following data is part of a premarket notification filed by Rovers B.v. with the FDA for Viba-brush.
| Device ID | K933870 |
| 510k Number | K933870 |
| Device Name: | VIBA-BRUSH |
| Classification | Spatula, Cervical, Cytological |
| Applicant | ROVERS B.V. 15 NO. MILL ST. Nyack, NY 10960 |
| Contact | Thomas J Swift |
| Correspondent | Thomas J Swift ROVERS B.V. 15 NO. MILL ST. Nyack, NY 10960 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-06 |
| Decision Date | 1995-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28719189246258 | K933870 | 000 |
| 28719189246227 | K933870 | 000 |
| 08719189246575 | K933870 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VIBA-BRUSH 74428532 1863619 Dead/Cancelled |
Rovers BV 1993-08-25 |