The following data is part of a premarket notification filed by Intact Medical Corporation with the FDA for Intact Breast Lesion Excision System With Intact Excision Xl.
| Device ID | K081057 |
| 510k Number | K081057 |
| Device Name: | INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL |
| Classification | Instrument, Biopsy |
| Applicant | INTACT MEDICAL CORPORATION ONE APPLE HILL SUITE 316 Natick, MA 01760 |
| Contact | Douglas Macarthur |
| Correspondent | Douglas Macarthur 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 | 2008-04-14 |
| Decision Date | 2008-06-17 |
| Summary: | summary |