Cleared Traditional

8 EMESIS BASIN

K771733 · Bemis Health Care · General Hospital
Sep 1977
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K771733 is an FDA 510(k) clearance for the 8 EMESIS BASIN, a Basin, Emesis (Class I — General Controls, product code FNY), submitted by Bemis Health Care (Mchenry, US). The FDA issued a Cleared decision on September 28, 1977, 13 days after receiving the submission on September 15, 1977. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6730.

Submission Details

510(k) Number K771733 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1977
Decision Date September 28, 1977
Days to Decision 13 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