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510(k) K073401

EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 by Micromedics, Inc. — Product Code MJV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2008
Date Received
December 4, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Inflation, Middle Ear
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

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