Cleared Traditional

GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES

K062672 · Grace Medical, Inc. · Ear, Nose, Throat
Oct 2006
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K062672 is an FDA 510(k) clearance for the GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES, a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on October 24, 2006, 46 days after receiving the submission on September 8, 2006. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number K062672 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2006
Decision Date October 24, 2006
Days to Decision 46 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETD — Tube, Tympanostomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3880

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