The following data is part of a premarket notification filed by Paragon Medical with the FDA for Stryker Chestshield Sterilization Tray System.
| Device ID | K183701 |
| 510k Number | K183701 |
| Device Name: | Stryker ChestShield Sterilization Tray System |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Paragon Medical 8 Matchett Dr. Pierceton, IN 46562 |
| Contact | Rebecca Walker |
| Correspondent | Rebecca Walker Paragon Medical 8 Matchett Dr Pierceton, IN 46562 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-31 |
| Decision Date | 2019-05-07 |