The following data is part of a premarket notification filed by Unisis Corp. with the FDA for Uniever Disposable Epidural Anesthesia Needle, Uniever Disposable Nerve Blocked Needle.
| Device ID | K142553 |
| 510k Number | K142553 |
| Device Name: | UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | UNISIS CORP. 2675-1, NISHIKATA Koshigaya-shi, JP 3430822 |
| Contact | Tadashi Yasuda |
| Correspondent | Diane Rutherford KEN BLOCK CONSULTING 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 -4403 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-10 |
| Decision Date | 2015-01-14 |
| Summary: | summary |