The following data is part of a premarket notification filed by Gunze Limited with the FDA for Neoveil Staple Line Reinforcement.
| Device ID | K221487 |
| 510k Number | K221487 |
| Device Name: | NEOVEIL Staple Line Reinforcement |
| Classification | Mesh, Surgical, Absorbable, Staple Line Reinforcement |
| 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 | OXC |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-23 |
| Decision Date | 2022-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04973077713783 | K221487 | 000 |
| 04973077713776 | K221487 | 000 |