The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Gyrus Ent Nerve Stimulator.
| Device ID | K021595 |
| 510k Number | K021595 |
| Device Name: | GYRUS ENT NERVE STIMULATOR |
| Classification | Stimulator, Nerve |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Greg Sredin |
| Correspondent | Greg Sredin GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-15 |
| Decision Date | 2002-10-24 |
| Summary: | summary |