The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Olympus Instrument Tray.
| Device ID | K110748 |
| 510k Number | K110748 |
| Device Name: | OLYMPUS INSTRUMENT TRAY |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY Center Valley, PA 18034 -0610 |
| Contact | Stacy Kluesner |
| Correspondent | Stacy Kluesner OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY Center Valley, PA 18034 -0610 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-17 |
| Decision Date | 2012-02-15 |
| Summary: | summary |