Cleared Traditional

DIMENSIONALL ROTATOR

K790753 · American Hospital Supply Corp. · Immunology
Jun 1979
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K790753 is an FDA 510(k) clearance for the DIMENSIONALL ROTATOR, a Shaker/stirrer (Class I — General Controls, product code JRQ), submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1979, 72 days after receiving the submission on April 17, 1979. This device falls under the Immunology review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K790753 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 1979
Decision Date June 28, 1979
Days to Decision 72 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JRQ — Shaker/stirrer
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050