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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K102598
Device Name HI-DOW-XP
Applicant
HI-DOW INTERNATIONAL INC.
2071 CONGRESSIONAL DR
ST LOUIS,  MO  63146
Applicant Contact ERIC CHEN
Correspondent
HI-DOW INTERNATIONAL INC.
2071 CONGRESSIONAL DR
ST LOUIS,  MO  63146
Correspondent Contact ERIC CHEN
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received09/10/2010
Decision Date 05/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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