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 |