The following data is part of a premarket notification filed by Intact Medical Corporation with the FDA for Intact Advance And Intact Excision Xl, Intact Bles.
| Device ID | K142477 |
| 510k Number | K142477 |
| Device Name: | Intact Advance And Intact Excision XL, Intact BLES |
| Classification | Instrument, Biopsy |
| Applicant | INTACT MEDICAL CORPORATION 550 COCHITUATE RD SUITE 25 Framingham, MA 01701 |
| Contact | John Vacha |
| Correspondent | John J Smith HOGAN LOVELLS US LLP 555 THIRTEENTH STREET. NW Washington, DC 20004 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-03 |
| Decision Date | 2014-12-15 |
| Summary: | summary |