K831580 is an FDA 510(k) clearance for the PARAFFIN INFILTRATION MEDIUM. This device is classified as a Formulations, Paraffin, All (Class I - General Controls, product code KEO).
Submitted by Surgipath Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 17, 1983, 31 days after receiving the submission on May 17, 1983.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.4010.
| 510(k) Number | K831580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 1983 |
| Decision Date | June 17, 1983 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KEO — Formulations, Paraffin, All |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.4010 |