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U.S. Department of Health and Human Services

Devices@FDA
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Device Classification Name Device, Inflation, Middle Ear
510(k) Number K073401
Device Name EARPOPPER, MODEL EP-2000, EP-2100, EP-3000
Applicant
Micromedics, Inc.
1270 Eagan Industrial Rd., Suite 120
St. Paul,  MN  55121
Applicant Contact TOM LOPAC
Correspondent
Micromedics, Inc.
1270 Eagan Industrial Rd., Suite 120
St. Paul,  MN  55121
Correspondent Contact TOM LOPAC
Classification Product Code
MJV  
Date Received12/04/2007
Decision Date 03/14/2008
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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