The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Versatube Tapered Tracheostomy Tube With Disposable Inner Cannula, Multiple, Prefixes C-vt, C-vtic.
| Device ID | K100283 |
| 510k Number | K100283 |
| Device Name: | VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | COOK, INC. 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Susanne Galin |
| Correspondent | Susanne Galin COOK, INC. 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-01 |
| Decision Date | 2010-04-23 |
| Summary: | summary |