The following data is part of a premarket notification filed by Cirdan Imaging Limited with the FDA for Corelite X-ray Specimen Cabinet.
| Device ID | K193317 |
| 510k Number | K193317 |
| Device Name: | CoreLite X-Ray Specimen Cabinet |
| Classification | Cabinet, X-ray System |
| Applicant | Cirdan Imaging Limited 8 Enterprise Crescent, Ballinderry Road Lisburn, GB Bt28 2bp |
| Contact | Jenna Mcgarry |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MWP |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-11-29 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060508820017 | K193317 | 000 |