The following data is part of a premarket notification filed by Teknar, Inc. with the FDA for Pro-cut Biopsy Needle.
| Device ID | K891777 |
| 510k Number | K891777 |
| Device Name: | PRO-CUT BIOPSY NEEDLE |
| Classification | Biopsy Needle |
| Applicant | TEKNAR, INC. 267 WOLFNER DR. Fenton, MO 63026 -2801 |
| Contact | James D Taylor |
| Correspondent | James D Taylor TEKNAR, INC. 267 WOLFNER DR. Fenton, MO 63026 -2801 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-24 |
| Decision Date | 1989-05-04 |