The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Wound Matrix (macro-channels).
| Device ID | K210128 |
| 510k Number | K210128 |
| Device Name: | INTEGRA Wound Matrix (Macro-Channels) |
| Classification | Dressing, Wound, Collagen |
| Applicant | Integra LifeSciences Corporation 1100 Campus Road Princeton, NJ 08540 |
| Contact | Saakshi Arora-tice |
| Correspondent | Nicole Kotter Integra LifeSciences Corporation 1100 Campus Road Princeton, NJ 08540 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-10-08 |