Cleared Traditional

MICROSURGICAL INSTRUMENTS

Jul 1993
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K932169 is an FDA 510(k) clearance for the MICROSURGICAL INSTRUMENTS, a Instrument, Microsurgical (Class I — General Controls, product code GZX), submitted by American Russian Medical Services, Inc. (Jackson, US). The FDA issued a Cleared decision on July 20, 1993, 76 days after receiving the submission on May 5, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4525.

Submission Details

510(k) Number K932169 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1993
Decision Date July 20, 1993
Days to Decision 76 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

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

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