The following data is part of a premarket notification filed by Wolfe Tory Medical, Inc. with the FDA for Laryngo-tracheal Mucosal Atomization Device (madgic).
| Device ID | K002255 |
| 510k Number | K002255 |
| Device Name: | LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) |
| Classification | Applicator (laryngo-tracheal), Topical Anesthesia |
| Applicant | WOLFE TORY MEDICAL, INC. 79 WEST 4500 SOUTH, SUITE 21 Salt Lake City, UT 84107 |
| Contact | Tim Wolfe |
| Correspondent | Tim Wolfe WOLFE TORY MEDICAL, INC. 79 WEST 4500 SOUTH, SUITE 21 Salt Lake City, UT 84107 |
| Product Code | CCT |
| CFR Regulation Number | 868.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-25 |
| Decision Date | 2000-09-18 |