The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Wholey (tm) Biopsy Device.
| Device ID | K874928 |
| 510k Number | K874928 |
| Device Name: | WHOLEY (TM) BIOPSY DEVICE |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Contact | Ruey C Dempsey |
| Correspondent | Ruey C Dempsey MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-02 |
| Decision Date | 1987-12-30 |