The following data is part of a premarket notification filed by Wolfe Tory Medical, Inc. with the FDA for Madett.
| Device ID | K021044 |
| 510k Number | K021044 |
| Device Name: | MADETT |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | WOLFE TORY MEDICAL, INC. 79 WEST 4500 SOUTH, SUITE 16 Salt Lake City, UT 84107 |
| Contact | Tim Wolfe |
| Correspondent | Tim Wolfe WOLFE TORY MEDICAL, INC. 79 WEST 4500 SOUTH, SUITE 16 Salt Lake City, UT 84107 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-01 |
| Decision Date | 2002-09-11 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MADETT 85299039 4172723 Dead/Cancelled |
Wolfe Tory Medical, Inc. 2011-04-19 |