Cleared Traditional

DOSIMETRIC RELEASE

K830546 · American Hospital Supply Corp. · Gastroenterology & Urology
May 1983
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K830546 is an FDA 510(k) clearance for the DOSIMETRIC RELEASE, a Evacuator, Gastro-urology (Class II — Special Controls, product code KQT), submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1983, 92 days after receiving the submission on February 22, 1983. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4370.

Submission Details

510(k) Number K830546 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 1983
Decision Date May 25, 1983
Days to Decision 92 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KQT — Evacuator, Gastro-urology
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4370