K120828 is an FDA 510(k) clearance for the BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES. This device is classified as a Dressing, Wound, Drug.
Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on April 5, 2012, 17 days after receiving the submission on March 19, 2012.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K120828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2012 |
| Decision Date | April 05, 2012 |
| Days to Decision | 17 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |