Cleared Traditional

MICROSURGICAL KERATOME

K890216 · Kinetic Medical Products · Neurology
Feb 1989
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K890216 is an FDA 510(k) clearance for the MICROSURGICAL KERATOME, a Instrument, Microsurgical (Class I — General Controls, product code GZX), submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on February 16, 1989, 29 days after receiving the submission on January 18, 1989. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4525.

Submission Details

510(k) Number K890216 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 1989
Decision Date February 16, 1989
Days to Decision 29 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GZX — Instrument, Microsurgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.4525

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