The following data is part of a premarket notification filed by Scandimed. A.s. with the FDA for Auto-band Ligator.
| Device ID | K031236 |
| 510k Number | K031236 |
| Device Name: | AUTO-BAND LIGATOR |
| Classification | Ligator, Esophageal |
| Applicant | SCANDIMED. A.S. SLOTSHERRENSVEJ 409 Glostrop, DK Dk 2600 |
| Contact | Kristian K Jensen |
| Correspondent | Kristian K Jensen SCANDIMED. A.S. SLOTSHERRENSVEJ 409 Glostrop, DK Dk 2600 |
| Product Code | MND |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-18 |
| Decision Date | 2003-11-14 |