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510(k) K110636

TULA IONTOPHORESIS SYSTEM by Acclarent, Inc. — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2011
Date Received
March 4, 2011
Clearance Type
Traditional
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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