RELIMESH
Mesh, Surgical, Polymeric
HERNIAMESH S.R.L.
The following data is part of a premarket notification filed by Herniamesh S.r.l. with the FDA for Relimesh.
Pre-market Notification Details
| Device ID | K081327 |
| 510k Number | K081327 |
| Device Name: | RELIMESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | HERNIAMESH S.R.L. 8 ORANGE DR. Jericho, NY 11753 |
| Contact | Lorena Trabucco |
| Correspondent | Lorena Trabucco HERNIAMESH S.R.L. 8 ORANGE DR. Jericho, NY 11753 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-12 |
| Decision Date | 2008-06-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18032919891560 | K081327 | 000 |
Trademark Results [RELIMESH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RELIMESH 79063579 3731600 Dead/Cancelled |
HERNIAMESH S.R.L. 2008-07-22 |
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