Cleared Traditional

BINOCULAR OPERATING MICROSCOPES &

K822012 · Kelleher Corp. · Neurology
Jul 1982
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K822012 is an FDA 510(k) clearance for the BINOCULAR OPERATING MICROSCOPES &, a Chair, Neurosurgical (Class I — General Controls, product code HBN), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1982, 22 days after receiving the submission on July 8, 1982. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4125.

Submission Details

510(k) Number K822012 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1982
Decision Date July 30, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code HBN — Chair, Neurosurgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.4125