The following data is part of a premarket notification filed by Gunze Limited with the FDA for Pelnac Meshed Bilayer Wound Matrix.
| Device ID | K213498 |
| 510k Number | K213498 |
| Device Name: | PELNAC Meshed Bilayer Wound Matrix |
| Classification | Dressing, Wound, Collagen |
| Applicant | Gunze Limited 46 Natsumegaichi, Aono Ayabe, Kyoto, JP 623-8513 |
| Contact | Hidenori Nishioka |
| Correspondent | Stuart R Goldman Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| 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 | 2021-11-01 |
| Decision Date | 2022-07-14 |