The following data is part of a premarket notification filed by American V. Mueller with the FDA for Field-lee Brain Biopsy Needle.
| Device ID | K801760 |
| 510k Number | K801760 |
| Device Name: | FIELD-LEE BRAIN BIOPSY NEEDLE |
| Classification | Instrument, Surgical, Non-powered |
| Applicant | AMERICAN V. MUELLER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HAO |
| CFR Regulation Number | 882.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-28 |
| Decision Date | 1980-09-09 |