The following data is part of a premarket notification filed by Scandimed International with the FDA for Modification To Auto-band Ligator.
| Device ID | K083556 |
| 510k Number | K083556 |
| Device Name: | MODIFICATION TO AUTO-BAND LIGATOR |
| Classification | Ligator, Esophageal |
| Applicant | SCANDIMED INTERNATIONAL 29 FRIGATE ST. Jamestown, RI 02835 |
| Contact | Stephen M Page |
| Correspondent | Stephen M Page SCANDIMED INTERNATIONAL 29 FRIGATE ST. Jamestown, RI 02835 |
| Product Code | MND |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-02 |
| Decision Date | 2009-02-19 |
| Summary: | summary |