The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Gyrus Acmi Telescope Storage-sterilization Tray.
| Device ID | K120474 |
| 510k Number | K120474 |
| Device Name: | GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Graham Baille |
| Correspondent | Graham Baille GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-16 |
| Decision Date | 2012-07-10 |
| Summary: | summary |