The following data is part of a premarket notification filed by Quotient Medical with the FDA for Sonishield 100 Antimicrobial Ultrasound Gel.
| Device ID | K151070 |
| 510k Number | K151070 |
| Device Name: | Sonishield 100 Antimicrobial Ultrasound Gel |
| Classification | Media, Coupling, Ultrasound |
| Applicant | Quotient Medical 3365 Harvester Road, Suite 110 Burlington, CA L7n 3n2 |
| Contact | David Okamoto |
| Correspondent | Marilyn Lockhart Lockhart Regulatory Services Inc. 1860 Appleby Line, Suite 348 Burlington, CA L7l 7h7 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-21 |
| Decision Date | 2016-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885914077436 | K151070 | 000 |
| 00628108100370 | K151070 | 000 |
| 00628108100363 | K151070 | 000 |
| 00628108100356 | K151070 | 000 |
| 10885914077440 | K151070 | 000 |