The following data is part of a premarket notification filed by Medicia Medical Products with the FDA for Mediziv Spinal Needle Set.
| Device ID | K925831 |
| 510k Number | K925831 |
| Device Name: | MEDIZIV SPINAL NEEDLE SET |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | MEDICIA MEDICAL PRODUCTS 88, WEIZMAN ST. Tel-aviv 62264 Israel, IL |
| Contact | Miri Sany |
| Correspondent | Miri Sany MEDICIA MEDICAL PRODUCTS 88, WEIZMAN ST. Tel-aviv 62264 Israel, IL |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-16 |
| Decision Date | 1993-07-16 |