The following data is part of a premarket notification filed by Neothermia Corp. with the FDA for En-bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302.
| Device ID | K020031 |
| 510k Number | K020031 |
| Device Name: | EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NEOTHERMIA CORP. ONE APPLE HILL SUITE 316 Natick, MA 01760 |
| Contact | Sherrie Coval-goldsmith |
| Correspondent | Sherrie Coval-goldsmith 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 | 2002-01-04 |
| Decision Date | 2002-03-27 |
| Summary: | summary |