NEOVEIL
Mesh, Surgical, Absorbable, Staple Line Reinforcement
GUNZE LIMITED
The following data is part of a premarket notification filed by Gunze Limited with the FDA for Neoveil.
Pre-market Notification Details
| Device ID | K130997 |
| 510k Number | K130997 |
| Device Name: | NEOVEIL |
| Classification | Mesh, Surgical, Absorbable, Staple Line Reinforcement |
| Applicant | GUNZE LIMITED 46 NATSUMEGAICHI, AONO Ayabe, Kyoto, JP 623-8513 |
| Contact | Nobuya Onishi |
| Correspondent | Nobuya Onishi GUNZE LIMITED 46 NATSUMEGAICHI, AONO Ayabe, Kyoto, JP 623-8513 |
| Product Code | OXC |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-10 |
| Decision Date | 2013-11-15 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548366322481 | K130997 | 000 |
| 04547301462558 | K130997 | 000 |
| 04547301462534 | K130997 | 000 |
Trademark Results [NEOVEIL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEOVEIL 85830084 not registered Dead/Abandoned |
GUNZE LIMITED 2013-01-23 |
 NEOVEIL 79129550 4445798 Live/Registered |
GUNZE LIMITED 2013-02-08 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.