K161212 is an FDA 510(k) clearance for the Atteris Antimicrobial Skin Protectant. This device is classified as a Dressing, Wound, Drug.
Submitted by Rochal Industries, LLC (San Antonio, US). The FDA issued a Cleared decision on September 30, 2016, 155 days after receiving the submission on April 28, 2016.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K161212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2016 |
| Decision Date | September 30, 2016 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |