The following data is part of a premarket notification filed by Neothermia Corp. with the FDA for Modification To En-bloc Biopsy System.
| Device ID | K033427 |
| 510k Number | K033427 |
| Device Name: | MODIFICATION TO EN-BLOC BIOPSY SYSTEM |
| Classification | Instrument, Biopsy |
| 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 | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-28 |
| Decision Date | 2003-11-10 |
| Summary: | summary |