The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Tru-cut Biopsy/aspira-needle 2n2709.
| Device ID | K831392 |
| 510k Number | K831392 |
| Device Name: | TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709 |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-29 |
| Decision Date | 1983-07-12 |