The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Chf-y0005.
| Device ID | K113120 |
| 510k Number | K113120 |
| Device Name: | CHF-Y0005 |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Sheri Musgnung |
| Correspondent | Sheri Musgnung OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | FBN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-21 |
| Decision Date | 2012-09-25 |
| Summary: | summary |