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 |