K200835 is an FDA 510(k) clearance for the 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad. This device is classified as a Dressing, Wound, Drug.
Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on September 4, 2020, 157 days after receiving the submission on March 31, 2020.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K200835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2020 |
| Decision Date | September 04, 2020 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |