K905688 is an FDA 510(k) clearance for the CUTINOVA HYDRO. This device is classified as a Beads, Hydrophilic, For Wound Exudate Absorption (Class I - General Controls, product code KOZ).
Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on April 1, 1991, 103 days after receiving the submission on December 19, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4018.
| 510(k) Number | K905688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 1990 |
| Decision Date | April 01, 1991 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KOZ — Beads, Hydrophilic, For Wound Exudate Absorption |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4018 |