The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Bivona Flextend Pediatric & Neonatal Tracheostromy Tubes.
| Device ID | K944178 |
| 510k Number | K944178 |
| Device Name: | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES |
| Classification | Tube Tracheostomy And Tube Cuff |
| 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 | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-26 |
| Decision Date | 1994-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688518248 | K944178 | 000 |
| 10351688518156 | K944178 | 000 |
| 10351688518163 | K944178 | 000 |
| 10351688518170 | K944178 | 000 |
| 10351688518187 | K944178 | 000 |
| 10351688518194 | K944178 | 000 |
| 10351688518200 | K944178 | 000 |
| 10351688518217 | K944178 | 000 |
| 10351688518224 | K944178 | 000 |
| 10351688518231 | K944178 | 000 |
| 10351688518149 | K944178 | 000 |