The following data is part of a premarket notification filed by Superior Plastic Products Corp. with the FDA for Sterile Water 4oz..
| Device ID | K812312 |
| 510k Number | K812312 |
| Device Name: | STERILE WATER 4OZ. |
| Classification | Catheter And Tip, Suction |
| Applicant | SUPERIOR PLASTIC PRODUCTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-17 |
| Decision Date | 1981-11-13 |