The following data is part of a premarket notification filed by Superior Plastic Products Corp. with the FDA for Silicone Sump Drain 20 & 40 French.
| Device ID | K840324 |
| 510k Number | K840324 |
| Device Name: | SILICONE SUMP DRAIN 20 & 40 FRENCH |
| Classification | Catheter, Infusion |
| Applicant | SUPERIOR PLASTIC PRODUCTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JCY |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-25 |
| Decision Date | 1984-04-25 |