The following data is part of a premarket notification filed by Neothermia Corporation with the FDA for Modification To En-bloc Biopsy System.
| Device ID | K052246 |
| 510k Number | K052246 |
| Device Name: | MODIFICATION TO EN-BLOC BIOPSY SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NEOTHERMIA CORPORATION ONE APPLE HILL SUITE 316 Natick, MA 01760 |
| Contact | David Jacobs |
| Correspondent | David Jacobs NEOTHERMIA CORPORATION 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 | 2005-08-17 |
| Decision Date | 2005-08-22 |
| Summary: | summary |