The following data is part of a premarket notification filed by Cruxell Corp. with the FDA for Cruxcan (crx-1000).
| Device ID | K183637 |
| 510k Number | K183637 |
| Device Name: | Cruxcan (CRX-1000) |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Cruxell Corp. A-405, Migun Techno World II 187 Techno 2-ro, Yuseong-gu Daejeon, KR 34025 |
| Contact | Daeseok Hwang |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, CA 92620 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800049600016 | K183637 | 000 |