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FDA 510(k) Application Details - K100246
Device Classification Name
Interferential Current Therapy
More FDA Info for this Device
510(K) Number
K100246
Device Name
Interferential Current Therapy
Applicant
BIO PROTECH, INC.
3010 LBJ FRWY.
12TH FLOOR
DALLAS, TX 75234 US
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Contact
JUDY BURTON
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/27/2010
Decision Date
11/24/2010
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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