The following data is part of a premarket notification filed by Medsource International, Llc. with the FDA for Medsource Endotracheal Tube (with And Without Cuff).
| Device ID | K080339 |
| 510k Number | K080339 |
| Device Name: | MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | MEDSOURCE INTERNATIONAL, LLC. 11715 FOX ROAD SUITE 400-180 Indianapolis, IN 46236 |
| Contact | Howard T Cooper |
| Correspondent | Howard T Cooper MEDSOURCE INTERNATIONAL, LLC. 11715 FOX ROAD SUITE 400-180 Indianapolis, IN 46236 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-08 |
| Decision Date | 2008-10-27 |
| Summary: | summary |