K983394 is an FDA 510(k) clearance for the MODIFICATION TO TIELLE HYDROPOLMER DRESSING. This device is classified as a Dressing, Wound And Burn, Occlusive.
Submitted by Johnson & Johnson Medical, Div. of Ethicon, Inc. (Arlington, US). The FDA issued a Cleared decision on November 3, 1998, 39 days after receiving the submission on September 25, 1998.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K983394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1998 |
| Decision Date | November 03, 1998 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MGP — Dressing, Wound And Burn, Occlusive |
| Device Class | — |