The following data is part of a premarket notification filed by Te Me Na S.a.r.l. with the FDA for Te Me Na Epidural Catheter.
| Device ID | K991259 |
| 510k Number | K991259 |
| Device Name: | TE ME NA EPIDURAL CATHETER |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | TE ME NA S.A.R.L. 390 SCARLET BLVD. Oldsmar, FL 34677 |
| Contact | Joe Harms |
| Correspondent | Joe Harms TE ME NA S.A.R.L. 390 SCARLET BLVD. Oldsmar, FL 34677 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-13 |
| Decision Date | 2001-02-21 |