K831728 is an FDA 510(k) clearance for the MEDICALEX. This device is classified as a Bandage, Elastic (Class I - General Controls, product code FQM).
Submitted by Medicalex (Mchenry, US). The FDA issued a Cleared decision on January 9, 1984, 223 days after receiving the submission on May 31, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5075.
| 510(k) Number | K831728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 1983 |
| Decision Date | January 09, 1984 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FQM — Bandage, Elastic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5075 |