Cleared Traditional

EARPOPPER, MODEL EP-2000, EP-2100, EP-3000

K073401 · Micromedics, Inc. · Ear, Nose, Throat

Mar 2008

Decision

101d

Days

—

Risk

About This 510(k) Submission

K073401 is an FDA 510(k) clearance for the EARPOPPER, MODEL EP-2000, EP-2100, EP-3000, a Device, Inflation, Middle Ear, submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 14, 2008, 101 days after receiving the submission on December 4, 2007. This device falls under the Ear, Nose, Throat review panel.

Submission Details

510(k) Number	K073401 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 2007
Decision Date	March 14, 2008
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF