Cleared Traditional

GRIESHABER TWO FUNCTION MANIPULATOR

K914585 · Grieshaber & Co. · Ear, Nose, Throat
Jan 1992
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K914585 is an FDA 510(k) clearance for the GRIESHABER TWO FUNCTION MANIPULATOR, a Source, Carrier, Fiberoptic Light (Class I — General Controls, product code EQH), submitted by Grieshaber & Co. (Langhorne, US). The FDA issued a Cleared decision on January 3, 1992, 79 days after receiving the submission on October 16, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4350.

Submission Details

510(k) Number K914585 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1991
Decision Date January 03, 1992
Days to Decision 79 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code EQH — Source, Carrier, Fiberoptic Light
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4350

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