K946269 is an FDA 510(k) clearance for the CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC POLYURETHANE FOAM DRESSINGS. This device is classified as a Bandage, Liquid (Class I — General Controls, product code KMF).
Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on January 12, 1995, 20 days after receiving the submission on December 23, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5090.
| 510(k) Number | K946269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1994 |
| Decision Date | January 12, 1995 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KMF — Bandage, Liquid |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.5090 |