Cleared Traditional

MULLAN GANGLION MICROCOMPRESSION SET

K940973 · Cook, Inc. · Neurology
Sep 1995
Decision
575d
Days
Class 1
Risk

About This 510(k) Submission

K940973 is an FDA 510(k) clearance for the MULLAN GANGLION MICROCOMPRESSION SET, a Instrument, Surgical, Non-powered (Class I — General Controls, product code HAO), submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on September 29, 1995, 575 days after receiving the submission on March 3, 1994. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4535.

Submission Details

510(k) Number K940973 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1994
Decision Date September 29, 1995
Days to Decision 575 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAO — Instrument, Surgical, Non-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.4535

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