The following data is part of a premarket notification filed by Intact Medical Corporation with the FDA for Intact Breast Lesion Excision System And Advance.
| Device ID | K060413 |
| 510k Number | K060413 |
| Device Name: | INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE |
| Classification | Instrument, Biopsy |
| Applicant | INTACT MEDICAL CORPORATION ONE APPLE HILL SUITE 316 Natick, MA 01760 |
| Contact | David Jacobs |
| Correspondent | David Jacobs INTACT MEDICAL CORPORATION ONE APPLE HILL SUITE 316 Natick, MA 01760 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-16 |
| Decision Date | 2006-04-27 |
| Summary: | summary |