The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Plexufix Brachial Plexus Anesth. Needle.
| Device ID | K813165 |
| 510k Number | K813165 |
| Device Name: | PLEXUFIX BRACHIAL PLEXUS ANESTH. NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | BURRON MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-10 |
| Decision Date | 1981-12-03 |