The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Pf-8p Oes Pancreato Fiberscope And Accessories.
| Device ID | K942338 |
| 510k Number | K942338 |
| Device Name: | OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-16 |
| Decision Date | 1994-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170160028 | K942338 | 000 |
| 04953170022975 | K942338 | 000 |