The following data is part of a premarket notification filed by Te Me Na S.a.r.l. with the FDA for Spinal Epidural Needles.
| Device ID | K002405 |
| 510k Number | K002405 |
| Device Name: | SPINAL EPIDURAL NEEDLES |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | TE ME NA S.A.R.L. 3234 ELLA LN. New Port Richey, FL 34655 |
| Contact | Art Ward |
| Correspondent | Art Ward TE ME NA S.A.R.L. 3234 ELLA LN. New Port Richey, FL 34655 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-07 |
| Decision Date | 2001-06-01 |