The following data is part of a premarket notification filed by Contour Fabricators Of Florida, Inc. with the FDA for Rns Sterile, Disposable Breast Biopsy/localization Tray.
| Device ID | K955683 |
| 510k Number | K955683 |
| Device Name: | RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY |
| Classification | Device, Percutaneous, Biopsy |
| Applicant | CONTOUR FABRICATORS OF FLORIDA, INC. 1247 FLORIDA AVE. Palm Harbor, FL 34683 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb CONTOUR FABRICATORS OF FLORIDA, INC. 1247 FLORIDA AVE. Palm Harbor, FL 34683 |
| Product Code | MJG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-14 |
| Decision Date | 1996-02-01 |