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 |