The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Optilene Mesh.
| Device ID | K061704 |
| 510k Number | K061704 |
| Device Name: | OPTILENE MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-16 |
| Decision Date | 2006-07-19 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OPTILENE MESH 87698100 not registered Live/Pending |
Aesculap AG 2017-11-27 |
![]() OPTILENE MESH 86187519 not registered Dead/Abandoned |
Aesculap AG 2014-02-07 |