K890107 is an FDA 510(k) clearance for the GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT. This device is classified as a Dressing, Wound, Drug.
Submitted by Premium Plastics, Inc. (Elkhorn, US). The FDA issued a Cleared decision on October 24, 1989, 286 days after receiving the submission on January 11, 1989.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K890107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | January 11, 1989 |
| Decision Date | October 24, 1989 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |