The following data is part of a premarket notification filed by Superior Plastic Products Corp. with the FDA for Silicone Suction & Irrigation Drain.
| Device ID | K840323 |
| 510k Number | K840323 |
| Device Name: | SILICONE SUCTION & IRRIGATION DRAIN |
| Classification | Catheter, Irrigation |
| Applicant | SUPERIOR PLASTIC PRODUCTS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GBX |
| 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 |