The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Modified Bivona Epistaxis Catheter.
| Device ID | K900583 |
| 510k Number | K900583 |
| Device Name: | MODIFIED BIVONA EPISTAXIS CATHETER |
| Classification | Balloon, Epistaxis |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Contact | Harry M Kaufman |
| Correspondent | Harry M Kaufman BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-07 |
| Decision Date | 1990-08-09 |