The following data is part of a premarket notification filed by Promex, Inc. with the FDA for Automated Core Biopsy Device.
| Device ID | K011270 |
| 510k Number | K011270 |
| Device Name: | AUTOMATED CORE BIOPSY DEVICE |
| Classification | Biopsy Needle |
| Applicant | PROMEX, INC. 3049 HUDSON ST. Franklin, IN 46131 |
| Contact | Joseph L Mark |
| Correspondent | Joseph L Mark PROMEX, INC. 3049 HUDSON ST. Franklin, IN 46131 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-26 |
| Decision Date | 2001-06-22 |