The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Sealguard Evac Endotracheal And Endotracheal Tubes.
| Device ID | K082520 |
| 510k Number | K082520 |
| Device Name: | SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | MALLINCKRODT MEDICAL 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Contact | Scott D Dickerhoff |
| Correspondent | Scott D Dickerhoff MALLINCKRODT MEDICAL 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-02 |
| Decision Date | 2008-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884521068180 | K082520 | 000 |
| 10884521211902 | K082520 | 000 |
| 10884521211896 | K082520 | 000 |
| 10884521211889 | K082520 | 000 |
| 20884522042335 | K082520 | 000 |
| 20884521068268 | K082520 | 000 |
| 20884521068251 | K082520 | 000 |
| 20884521068237 | K082520 | 000 |
| 20884521068220 | K082520 | 000 |
| 20884521068213 | K082520 | 000 |
| 20884521068206 | K082520 | 000 |
| 20884521068183 | K082520 | 000 |
| 20884522042403 | K082520 | 000 |
| 20884522042397 | K082520 | 000 |
| 10884521211872 | K082520 | 000 |
| 20884522042328 | K082520 | 000 |
| 20884521211770 | K082520 | 000 |
| 20884521211787 | K082520 | 000 |
| 30884521068265 | K082520 | 000 |
| 30884521068258 | K082520 | 000 |
| 30884521068234 | K082520 | 000 |
| 30884521068227 | K082520 | 000 |
| 30884521068210 | K082520 | 000 |
| 30884521068203 | K082520 | 000 |
| 20884522042410 | K082520 | 000 |
| 20884522042380 | K082520 | 000 |
| 20884522042373 | K082520 | 000 |
| 20884522042366 | K082520 | 000 |
| 20884522042359 | K082520 | 000 |
| 20884522042342 | K082520 | 000 |
| 20884521211817 | K082520 | 000 |
| 20884521211800 | K082520 | 000 |
| 20884521211794 | K082520 | 000 |
| 20884521211732 | K082520 | 000 |