The following data is part of a premarket notification filed by Orifice Medical Ab with the FDA for Oribrush - With Protective Tip - B001.
| Device ID | K991595 |
| 510k Number | K991595 |
| Device Name: | ORIBRUSH - WITH PROTECTIVE TIP - B001 |
| Classification | Spatula, Cervical, Cytological |
| Applicant | ORIFICE MEDICAL AB BRONSGATAN 12 Ystad, SE S-271 39 |
| Contact | Patric Nilsson |
| Correspondent | Patric Nilsson ORIFICE MEDICAL AB BRONSGATAN 12 Ystad, SE S-271 39 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-07 |
| Decision Date | 1999-06-29 |