The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Xtjf Type Q160vf1.
| Device ID | K080403 |
| 510k Number | K080403 |
| Device Name: | XTJF TYPE Q160VF1 |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Laura Storm-tyler |
| Correspondent | Laura Storm-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-14 |
| Decision Date | 2008-05-20 |
| Summary: | summary |