The following data is part of a premarket notification filed by Controlrad, Inc with the FDA for Controlrad Sterile Cover.
| Device ID | K200238 |
| 510k Number | K200238 |
| Device Name: | ControlRad Sterile Cover |
| Classification | Drape, Surgical |
| Applicant | ControlRad, Inc 275 Scientific Drive NW #1100 Norcross, GA 30092 |
| Contact | Chris Fair |
| Correspondent | Linda Braddon Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-31 |
| Decision Date | 2020-04-26 |