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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, iontophoresis, other uses
510(k) Number K133033
Device Name HIDREX PSP1000
Applicant
HIDREX GMBH
2611 SHARK CIRCLE
TEXAS CITY,  TX  77591
Applicant Contact STEFANIE D BANKSTON
Correspondent
HIDREX GMBH
2611 SHARK CIRCLE
TEXAS CITY,  TX  77591
Correspondent Contact STEFANIE D BANKSTON
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received09/26/2013
Decision Date 04/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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