Submission Details
| 510(k) Number | K943424 FDA.gov |
| FDA Decision | Cleared SN |
| Date Received | July 15, 1994 |
| Decision Date | October 03, 1994 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K943424 is an FDA 510(k) clearance for the CUSH ISLAND DRESSING. This device is classified as a Dressing, Wound And Burn, Occlusive.
Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on October 3, 1994, 80 days after receiving the submission on July 15, 1994.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K943424 FDA.gov |
| FDA Decision | Cleared SN |
| Date Received | July 15, 1994 |
| Decision Date | October 03, 1994 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | MGP — Dressing, Wound And Burn, Occlusive |
| Device Class | — |