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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name interferential current therapy
510(k) Number K003631
Device Name SMARTWAVE IF 2000
Applicant
NEWWAVE MEDICAL LLC.
620 HAGGARD ST. STE 614
PLANO,  TX  75074 -5530
Applicant Contact ROBERT ARMSTRONG
Correspondent
NEWWAVE MEDICAL LLC.
620 HAGGARD ST. STE 614
PLANO,  TX  75074 -5530
Correspondent Contact ROBERT ARMSTRONG
Regulation Number882.5890
Classification Product Code
LIH  
Date Received11/24/2000
Decision Date 08/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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