The following data is part of a premarket notification filed by Hr Pharmaceuticals, Inc. with the FDA for Ecovue Sterile And Non-sterile Ultrasound Gels.
| Device ID | K181363 |
| 510k Number | K181363 |
| Device Name: | EcoVue Sterile And Non-Sterile Ultrasound Gels |
| Classification | Media, Coupling, Ultrasound |
| Applicant | HR Pharmaceuticals, Inc. 2600 Eastern Boulevard Suite 201 York, PA 17402 |
| Contact | Colby Wiesman |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-05-23 |
| Decision Date | 2018-06-13 |
| Summary: | summary |