K801743 is an FDA 510(k) clearance for the PLASTAZOTE SHOE. This device is classified as a Orthosis, Corrective Shoe (Class I - General Controls, product code KNP).
Submitted by Alimed, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1980, 10 days after receiving the submission on July 28, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K801743 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 1980 |
| Decision Date | August 07, 1980 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | KNP — Orthosis, Corrective Shoe |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3475 |