Cleared Traditional

SURGI-QUIP MICROSCOPE STAND

K822428 · Surgi-Quip Inc.U · Pathology
Sep 1982
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K822428 is an FDA 510(k) clearance for the SURGI-QUIP MICROSCOPE STAND, a Chair, Neurosurgical (Class I — General Controls, product code HBN), submitted by Surgi-Quip Inc.U (Mchenry, US). The FDA issued a Cleared decision on September 2, 1982, 21 days after receiving the submission on August 12, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 882.4125.

Submission Details

510(k) Number K822428 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1982
Decision Date September 02, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

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