The following data is part of a premarket notification filed by Premium Plastics, Inc. with the FDA for Sterile Sponge Bowls.
| Device ID | K800440 |
| 510k Number | K800440 |
| Device Name: | STERILE SPONGE BOWLS |
| Classification | Basin, Emesis |
| Applicant | PREMIUM PLASTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FNY |
| CFR Regulation Number | 880.6730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-28 |
| Decision Date | 1980-04-29 |