The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Olympus Cf Type Y0023-l, Y0023i.
| Device ID | K101053 |
| 510k Number | K101053 |
| Device Name: | OLYMPUS CF TYPE Y0023-L, Y0023I |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION REGULATORY AFFAIRS & QUALITY 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Contact | Stacy A Kluesner |
| Correspondent | Stacy A Kluesner OLYMPUS MEDICAL SYSTEMS CORPORATION REGULATORY AFFAIRS & QUALITY 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-15 |
| Decision Date | 2010-07-14 |
| Summary: | summary |