The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Bivona Adjustable And Fixed Neckflange Hyperflex Tracheostomy Tubes.
| Device ID | K081440 |
| 510k Number | K081440 |
| Device Name: | BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | SMITHS MEDICAL ASD, INC. 6250 SHIER RINGS RD. Dublin, OH 43016 |
| Contact | Barbara Law |
| Correspondent | Barbara Law SMITHS MEDICAL ASD, INC. 6250 SHIER RINGS RD. Dublin, OH 43016 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-22 |
| Decision Date | 2008-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05021312013781 | K081440 | 000 |
| 15021312013832 | K081440 | 000 |
| 15021312013825 | K081440 | 000 |
| 15021312013818 | K081440 | 000 |
| 15021312013801 | K081440 | 000 |
| 15021312013795 | K081440 | 000 |
| 15021312013740 | K081440 | 000 |
| 15021312013733 | K081440 | 000 |
| 15021312013726 | K081440 | 000 |
| 15021312013719 | K081440 | 000 |
| 15021312013702 | K081440 | 000 |
| 15021312013696 | K081440 | 000 |
| 15021312013849 | K081440 | 000 |
| 15021312013856 | K081440 | 000 |
| 15021312013863 | K081440 | 000 |
| 05021312013774 | K081440 | 000 |
| 05021312013767 | K081440 | 000 |
| 05021312013750 | K081440 | 000 |
| 15021312015706 | K081440 | 000 |
| 15021312015690 | K081440 | 000 |
| 15021312015683 | K081440 | 000 |
| 15021312015676 | K081440 | 000 |
| 15021312015669 | K081440 | 000 |
| 15021312015652 | K081440 | 000 |
| 15021312015645 | K081440 | 000 |
| 15021312015638 | K081440 | 000 |
| 15021312013689 | K081440 | 000 |