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FDA 510(k) Application Details - K003631
Device Classification Name
Interferential Current Therapy
More FDA Info for this Device
510(K) Number
K003631
Device Name
Interferential Current Therapy
Applicant
NEWWAVE MEDICAL LLC.
620 HAGGARD ST. STE 614
PLANO, TX 75074-5530 US
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Contact
ROBERT ARMSTRONG
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LIH
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More FDA Info for this Product Code
Date Received
11/24/2000
Decision Date
08/10/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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