The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Olympus Choledochoscope, Model Xchf-bp160f.
| Device ID | K051886 |
| 510k Number | K051886 |
| Device Name: | OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -9058 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -9058 |
| Product Code | FBN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-12 |
| Decision Date | 2005-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170065163 | K051886 | 000 |