STERILE SPONGE BOWLS

Basin, Emesis

PREMIUM PLASTICS, INC.

The following data is part of a premarket notification filed by Premium Plastics, Inc. with the FDA for Sterile Sponge Bowls.

Pre-market Notification Details

Device IDK800440
510k NumberK800440
Device Name:STERILE SPONGE BOWLS
ClassificationBasin, Emesis
Applicant PREMIUM PLASTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFNY  
CFR Regulation Number880.6730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-02-28
Decision Date1980-04-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.