The following data is part of a premarket notification filed by Neothermia Corp. with the FDA for En Bloc Biopsy System.
| Device ID | K003190 |
| 510k Number | K003190 |
| Device Name: | EN BLOC BIOPSY SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NEOTHERMIA CORP. ONE APPLE HILL SUITE 316 Natick, MA 01760 |
| Contact | Sherrie Coval-goldmsith |
| Correspondent | Sherrie Coval-goldmsith NEOTHERMIA CORP. ONE APPLE HILL SUITE 316 Natick, MA 01760 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-11 |
| Decision Date | 2001-06-11 |