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510(k) K150453

TULA Iontophoresis System with Earset by Acclarent, Inc. — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2015
Date Received
February 20, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Other Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type

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