The following data is part of a premarket notification filed by Spinal Specialties, Inc. with the FDA for Gertie Marx Epi-spinal Tray.
| Device ID | K943319 |
| 510k Number | K943319 |
| Device Name: | GERTIE MARX EPI-SPINAL TRAY |
| Classification | Anesthesia Conduction Kit |
| Applicant | SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio, TX 78217 |
| Contact | Robert Keahey |
| Correspondent | Robert Keahey SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio, TX 78217 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-11 |
| Decision Date | 1995-06-30 |