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 |