The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Micromedics Sphenoid Sinus Stent.
| Device ID | K050340 |
| 510k Number | K050340 |
| Device Name: | MICROMEDICS SPHENOID SINUS STENT |
| Classification | Cannula, Sinus |
| Applicant | MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD SUITE 120 Eagan, MN 55121 |
| Contact | Thomas A Lopac |
| Correspondent | Thomas A Lopac MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD SUITE 120 Eagan, MN 55121 |
| Product Code | KAM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-11 |
| Decision Date | 2005-04-27 |