The following data is part of a premarket notification filed by Spinal Specialties, Inc. with the FDA for Spinal Specialties Pencil-point Spinal Needle.
| Device ID | K950820 |
| 510k Number | K950820 |
| Device Name: | SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio, TX 78217 |
| Contact | Michael Wakely |
| Correspondent | Michael Wakely 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 | 1995-02-23 |
| Decision Date | 1995-06-30 |