The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Beraha Biopsy Needles, 2n2730, 2n2731 & 2n2732.
| Device ID | K855003 |
| 510k Number | K855003 |
| Device Name: | BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732 |
| Classification | Instrument, Biopsy |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-13 |
| Decision Date | 1986-02-10 |