The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Madgic Laryngo-tracheal Mucosal Atomization Device.
| Device ID | K153470 |
| 510k Number | K153470 |
| Device Name: | MADgic Laryngo-Tracheal Mucosal Atomization Device |
| Classification | Applicator (laryngo-tracheal), Topical Anesthesia |
| Applicant | TELEFLEX MEDICAL 3015 Morrisville, NC 27560 |
| Contact | Kristen Bisanz |
| Correspondent | Kristen Bisanz TELEFLEX MEDICAL 3015 Morrisville, NC 27560 |
| Product Code | CCT |
| CFR Regulation Number | 868.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-02 |
| Decision Date | 2016-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 25060112313244 | K153470 | 000 |
| 24026704709872 | K153470 | 000 |
| 24026704709889 | K153470 | 000 |
| 24026704717532 | K153470 | 000 |
| 34026704717546 | K153470 | 000 |
| 34026704717553 | K153470 | 000 |
| 24026704613193 | K153470 | 000 |
| 34026704613213 | K153470 | 000 |
| 24026704613223 | K153470 | 000 |
| 25060112313176 | K153470 | 000 |
| 25060112313183 | K153470 | 000 |
| 15060112313209 | K153470 | 000 |
| 25060112313213 | K153470 | 000 |
| 25060112313220 | K153470 | 000 |
| 15060112313230 | K153470 | 000 |
| 34026704709862 | K153470 | 000 |