The following data is part of a premarket notification filed by Popper & Sons, Inc. with the FDA for Westerman-jensen Biopsy Needle.
| Device ID | K840168 |
| 510k Number | K840168 |
| Device Name: | WESTERMAN-JENSEN BIOPSY NEEDLE |
| Classification | Biopsy Needle |
| Applicant | POPPER & SONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-16 |
| Decision Date | 1984-03-12 |