The following data is part of a premarket notification filed by Safersonic Us, Inc. with the FDA for Safergel Sterile Ultrasound Gel.
| Device ID | K190591 |
| 510k Number | K190591 |
| Device Name: | Safergel Sterile Ultrasound Gel |
| Classification | Media, Coupling, Ultrasound |
| Applicant | Safersonic US, Inc. 2873 Arlington AV, Ste. 110 Highland Park, IL 60035 |
| Contact | David L. Seitelman |
| Correspondent | Kevin Walls Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-07 |
| Decision Date | 2019-10-04 |