The following data is part of a premarket notification filed by Neothermia Corporation with the FDA for En-bloc Biopsy System Model#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120.
| Device ID | K042170 |
| 510k Number | K042170 |
| Device Name: | EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NEOTHERMIA CORPORATION ONE APPLE HILL SUITE 316 Natick, MA 01760 |
| Contact | Sherrie Coval-goldsmith |
| Correspondent | Sherrie Coval-goldsmith NEOTHERMIA CORPORATION ONE APPLE HILL SUITE 316 Natick, MA 01760 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-11 |
| Decision Date | 2004-09-07 |
| Summary: | summary |