The following data is part of a premarket notification filed by Dynarex Corporation with the FDA for Dynarex Ultrasound Gel.
| Device ID | K102637 |
| 510k Number | K102637 |
| Device Name: | DYNAREX ULTRASOUND GEL |
| Classification | Media, Coupling, Ultrasound |
| Applicant | DYNAREX CORPORATION 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Contact | Daniel Consaga |
| Correspondent | Daniel Consaga DYNAREX CORPORATION 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-14 |
| Decision Date | 2011-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784124735 | K102637 | 000 |
| 00616784124537 | K102637 | 000 |
| 00616784124339 | K102637 | 000 |
| 00616784124131 | K102637 | 000 |