The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Fome-cuf-wire Re-enforced, Aire-cuf Wire.
| Device ID | K792035 |
| 510k Number | K792035 |
| Device Name: | FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-10 |
| Decision Date | 1979-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15021312014419 | K792035 | 000 |
| 15021312014211 | K792035 | 000 |
| 15021312014204 | K792035 | 000 |
| 15021312014198 | K792035 | 000 |
| 15021312014013 | K792035 | 000 |
| 15021312014006 | K792035 | 000 |
| 15021312013993 | K792035 | 000 |
| 15021312013986 | K792035 | 000 |
| 15021312013979 | K792035 | 000 |
| 15021312013962 | K792035 | 000 |
| 15021312013955 | K792035 | 000 |
| 15021312013948 | K792035 | 000 |
| 15021312013931 | K792035 | 000 |
| 15021312013924 | K792035 | 000 |
| 15021312013917 | K792035 | 000 |
| 15021312013900 | K792035 | 000 |
| 15021312013894 | K792035 | 000 |
| 15021312014228 | K792035 | 000 |
| 15021312014235 | K792035 | 000 |
| 15021312014242 | K792035 | 000 |
| 15021312014402 | K792035 | 000 |
| 15021312014396 | K792035 | 000 |
| 15021312014389 | K792035 | 000 |
| 15021312014372 | K792035 | 000 |
| 15021312014365 | K792035 | 000 |
| 15021312014358 | K792035 | 000 |
| 15021312014341 | K792035 | 000 |
| 15021312014334 | K792035 | 000 |
| 15021312014327 | K792035 | 000 |
| 15021312014310 | K792035 | 000 |
| 15021312014303 | K792035 | 000 |
| 15021312014297 | K792035 | 000 |
| 15021312014280 | K792035 | 000 |
| 15021312014273 | K792035 | 000 |
| 15021312014266 | K792035 | 000 |
| 15021312014259 | K792035 | 000 |
| 15021312013887 | K792035 | 000 |