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510(k) K951596

EARCLEAR by Arisil Medical — Product Code MJV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 24, 1995
Date Received: April 7, 1995
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