The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Endoscopic Ligation Device.
| Device ID | K001744 |
| 510k Number | K001744 |
| Device Name: | OLYMPUS ENDOSCOPIC LIGATION DEVICE |
| Classification | Ligator, Esophageal |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | MND |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-08 |
| Decision Date | 2001-02-27 |