The following data is part of a premarket notification filed by Olympus Corp Of America with the FDA for Olympus Hx-20 Series Ligating Device.
| Device ID | K984255 |
| 510k Number | K984255 |
| Device Name: | OLYMPUS HX-20 SERIES LIGATING DEVICE |
| Classification | Ligator, Esophageal |
| Applicant | OLYMPUS CORP OF AMERICA 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS CORP OF AMERICA 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Product Code | MND |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-30 |
| Decision Date | 1999-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170045028 | K984255 | 000 |
| 04953170044953 | K984255 | 000 |
| 04953170044946 | K984255 | 000 |
| 14953170044929 | K984255 | 000 |
| 04953170044885 | K984255 | 000 |
| 14953170044868 | K984255 | 000 |
| 04953170044823 | K984255 | 000 |
| 14953170044806 | K984255 | 000 |
| 04953170032554 | K984255 | 000 |