The following data is part of a premarket notification filed by Orison Corporation with the FDA for Embrace Gel.
| Device ID | K072515 |
| 510k Number | K072515 |
| Device Name: | EMBRACE GEL |
| Classification | Media, Coupling, Ultrasound |
| Applicant | ORISON CORPORATION 121 BOONE RIDGE DR. Johnson City, TN 37601 |
| Contact | Al Sandy |
| Correspondent | Daniel W Lohtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-09-07 |
| Decision Date | 2007-09-20 |
| Summary: | summary |