The following data is part of a premarket notification filed by Thd Lap with the FDA for Imesh Tacker.
| Device ID | K153202 |
| 510k Number | K153202 |
| Device Name: | IMESH Tacker |
| Classification | Staple, Implantable |
| Applicant | THD LAP 1 NIRIM ST. Tel Aviv, IL 6706036 |
| Contact | Einat Duvdevany |
| Correspondent | Einat Duvdevany THD LAP 1 NIRIM ST. Tel Aviv, IL 6706036 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-04 |
| Decision Date | 2016-03-24 |
| Summary: | summary |