The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Perfix Set For Epidural Anesthesia W/tuo.
| Device ID | K813186 |
| 510k Number | K813186 |
| Device Name: | PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO |
| Classification | Anesthesia Conduction Kit |
| Applicant | BURRON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-16 |
| Decision Date | 1981-12-03 |