The following data is part of a premarket notification filed by Scandimed International with the FDA for Auto-band Ligator.
| Device ID | K081142 |
| 510k Number | K081142 |
| Device Name: | AUTO-BAND LIGATOR |
| Classification | Ligator, Esophageal |
| Applicant | SCANDIMED INTERNATIONAL 409 SLOTSHERRENSVEJ Glostrop, DK Dk 2600 |
| Contact | Salah Chami |
| Correspondent | Salah Chami SCANDIMED INTERNATIONAL 409 SLOTSHERRENSVEJ Glostrop, DK Dk 2600 |
| Product Code | MND |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-22 |
| Decision Date | 2008-05-16 |
| Summary: | summary |