The following data is part of a premarket notification filed by Superior Plastic Products Corp. with the FDA for 3.5 & 5.5 Oz. Sodium Chloride Solution.
| Device ID | K820460 |
| 510k Number | K820460 |
| Device Name: | 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION |
| Classification | Catheter And Tip, Suction |
| Applicant | SUPERIOR PLASTIC PRODUCTS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-19 |
| Decision Date | 1982-03-08 |