The following data is part of a premarket notification filed by Cura Medical Technologies, Llc with the FDA for Cura Compensator.
| Device ID | K131150 |
| 510k Number | K131150 |
| Device Name: | CURA COMPENSATOR |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | CURA MEDICAL TECHNOLOGIES, LLC 23 RANCHO CIRCLE Lake Forest, CA 92630 |
| Contact | Thomas H Faris |
| Correspondent | Thomas H Faris CURA MEDICAL TECHNOLOGIES, LLC 23 RANCHO CIRCLE Lake Forest, CA 92630 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-23 |
| Decision Date | 2013-07-30 |
| Summary: | summary |