K840324 is an FDA 510(k) clearance for the SILICONE SUMP DRAIN 20 & 40 FRENCH. This device is classified as a Catheter, Infusion (Class I - General Controls, product code JCY).
Submitted by Superior Plastic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984, 91 days after receiving the submission on January 25, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K840324 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 1984 |
| Decision Date | April 25, 1984 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | JCY — Catheter, Infusion |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |