The following data is part of a premarket notification filed by Unisis Corp. with the FDA for Uniever Disposable Spinal Anesthesia Needle.
| Device ID | K141126 |
| 510k Number | K141126 |
| Device Name: | UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | UNISIS CORP. 1201 RICHARDSON DRIVE, SUITE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford UNISIS CORP. 1201 RICHARDSON DRIVE, SUITE 280 Richardson, TX 75080 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-01 |
| Decision Date | 2014-10-31 |
| Summary: | summary |