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510(k) K133033

HIDREX PSP1000 by Hidrex GmbH — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2015
Date Received
September 26, 2013
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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