The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Neurotology Drape, Model Tbd.
| Device ID | K002702 |
| 510k Number | K002702 |
| Device Name: | NEUROTOLOGY DRAPE, MODEL TBD |
| Classification | Drape, Surgical |
| 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 | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-30 |
| Decision Date | 2000-10-26 |