Cleared Traditional

K800440 - STERILE SPONGE BOWLS
(FDA 510(k) Clearance)

K800440 · Premium Plastics, Inc. · General Hospital
Apr 1980
Decision
61d
Days
Class 1
Risk

K800440 is an FDA 510(k) clearance for the STERILE SPONGE BOWLS, a Basin, Emesis (Class I — General Controls, product code FNY), submitted by Premium Plastics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1980, 61 days after receiving the submission on February 28, 1980. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6730.

Submission Details

510(k) Number K800440 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 1980
Decision Date April 29, 1980
Days to Decision 61 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FNY — Basin, Emesis
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6730