The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Hepafix Biopsy Needle Set.
| Device ID | K813085 |
| 510k Number | K813085 |
| Device Name: | HEPAFIX BIOPSY NEEDLE SET |
| Classification | Instrument, Biopsy |
| Applicant | BURRON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-02 |
| Decision Date | 1981-11-20 |