The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for G.e. Sterile Ct Biopsy Tray.
| Device ID | K960144 |
| 510k Number | K960144 |
| Device Name: | G.E. STERILE CT BIOPSY TRAY |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | GE MEDICAL SYSTEMS 1247 FLORDIA AVE. Palm Harbor, FL 34683 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb GE MEDICAL SYSTEMS 1247 FLORDIA AVE. Palm Harbor, FL 34683 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-16 |
| Decision Date | 1996-04-15 |