The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Single Use Splinting Tube, Models St-y0002-s, St-y0002-h, St-y0003-s And St-y0003-h.
| Device ID | K091759 |
| 510k Number | K091759 |
| Device Name: | SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 |
| Contact | Stacy Abbatiello Kluesner |
| Correspondent | Stacy Abbatiello Kluesner OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-16 |
| Decision Date | 2009-09-18 |
| Summary: | summary |