The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Various Fome-cuf Tracheal Tubes W/sideport Airway.
| Device ID | K853502 |
| 510k Number | K853502 |
| Device Name: | VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Contact | Shapiro |
| Correspondent | Shapiro 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 | 1985-08-21 |
| Decision Date | 1985-10-01 |