Cleared Traditional

SILVERSTEIN MICROWICK

K991670 · Micromedics, Inc. · Ear, Nose, Throat
Aug 1999
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K991670 is an FDA 510(k) clearance for the SILVERSTEIN MICROWICK, a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on August 26, 1999, 101 days after receiving the submission on May 17, 1999. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number K991670 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 1999
Decision Date August 26, 1999
Days to Decision 101 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

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

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