The following data is part of a premarket notification filed by Spinal Specialties, Inc. with the FDA for Epidural Needle.
| Device ID | K942863 |
| 510k Number | K942863 |
| Device Name: | EPIDURAL NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio, TX 78217 |
| Contact | Robert Keahney |
| Correspondent | Robert Keahney SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio, TX 78217 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-17 |
| Decision Date | 1995-08-11 |