K943363 is an FDA 510(k) clearance for the CUTIPLAST STERIL. This device is classified as a Dressing, Wound And Burn, Occlusive.
Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on March 15, 1995, 245 days after receiving the submission on July 13, 1994.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K943363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1994 |
| Decision Date | March 15, 1995 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MGP — Dressing, Wound And Burn, Occlusive |
| Device Class | — |