The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Tjf-140r/jf-140r Evis Duodenovideoscopes And Accessories, Olympus Maj-311/maj-411 Distal Covers.
| Device ID | K980465 |
| 510k Number | K980465 |
| Device Name: | OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tayler |
| Correspondent | Laura Storms-tayler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-05 |
| Decision Date | 1998-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170368612 | K980465 | 000 |
| 04953170339851 | K980465 | 000 |
| 14953170194648 | K980465 | 000 |
| 04953170071416 | K980465 | 000 |