The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Upd-y0003.
| Device ID | K103312 |
| 510k Number | K103312 |
| Device Name: | UPD-Y0003 |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Stacy Kluesner |
| Correspondent | Stacy Kluesner OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 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 | 2010-11-10 |
| Decision Date | 2011-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170313202 | K103312 | 000 |
| 04953170305764 | K103312 | 000 |
| 04953170305740 | K103312 | 000 |
| 04953170305726 | K103312 | 000 |
| 04953170305719 | K103312 | 000 |
| 04953170305702 | K103312 | 000 |
| 04953170305696 | K103312 | 000 |
| 04953170305689 | K103312 | 000 |
| 04953170305672 | K103312 | 000 |
| 04953170305665 | K103312 | 000 |
| 04953170026010 | K103312 | 000 |
| 04953170305771 | K103312 | 000 |
| 04953170305788 | K103312 | 000 |
| 04953170305887 | K103312 | 000 |
| 04953170305870 | K103312 | 000 |
| 04953170305863 | K103312 | 000 |
| 04953170305856 | K103312 | 000 |
| 04953170305849 | K103312 | 000 |
| 04953170305832 | K103312 | 000 |
| 04953170305825 | K103312 | 000 |
| 04953170305818 | K103312 | 000 |
| 04953170305801 | K103312 | 000 |
| 04953170305795 | K103312 | 000 |
| 04953170026003 | K103312 | 000 |