Cleared Special

CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861

K021479 · Heinz Kurz GmbH Medizintechnik · Ear, Nose, Throat
May 2002
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K021479 is an FDA 510(k) clearance for the CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861, a Prosthesis, Partial Ossicular Replacement (Class II — Special Controls, product code ETB), submitted by Heinz Kurz GmbH Medizintechnik (Amsterdam, Nh, NL). The FDA issued a Cleared decision on May 21, 2002, 13 days after receiving the submission on May 8, 2002. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3450.

Submission Details

510(k) Number K021479 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2002
Decision Date May 21, 2002
Days to Decision 13 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETB — Prosthesis, Partial Ossicular Replacement
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3450

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