The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Bivona Fome-cuf Laser Endotracheal Tube.
| Device ID | K862238 |
| 510k Number | K862238 |
| Device Name: | BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Contact | Shapiro, M.d. |
| Correspondent | Shapiro, M.d. BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-12 |
| Decision Date | 1986-10-15 |