The following data is part of a premarket notification filed by Easylap Ltd. with the FDA for Imesh Tacker.
| Device ID | K110728 |
| 510k Number | K110728 |
| Device Name: | IMESH TACKER |
| Classification | Staple, Implantable |
| Applicant | EASYLAP LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden EASYLAP LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-16 |
| Decision Date | 2011-06-08 |
| Summary: | summary |