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 |