K141603 is an FDA 510(k) clearance for the Ultra Silver Dressings. This device is classified as a Dressing, Wound, Drug.
Submitted by Milliken Healthcare Products, LLC (Marlborough, US). The FDA issued a Cleared decision on October 22, 2014, 128 days after receiving the submission on June 16, 2014.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K141603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2014 |
| Decision Date | October 22, 2014 |
| Days to Decision | 128 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |