Cleared Traditional

BASIN PACK

K802538 · Texas Medical Products, Inc. · General Hospital
Oct 1980
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K802538 is an FDA 510(k) clearance for the BASIN PACK, a Basin, Emesis (Class I — General Controls, product code FNY), submitted by Texas Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980, 16 days after receiving the submission on October 15, 1980. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6730.

Submission Details

510(k) Number K802538 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1980
Decision Date October 31, 1980
Days to Decision 16 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