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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 K100246
Device Name MAX-IF1000
Applicant
BIO PROTECH, INC.
3010 LBJ FRWY.
12TH FLOOR
DALLAS,  TX  75234
Applicant Contact JUDY BURTON
Correspondent
BIO PROTECH, INC.
3010 LBJ FRWY.
12TH FLOOR
DALLAS,  TX  75234
Correspondent Contact JUDY BURTON
Regulation Number882.5890
Classification Product Code
LIH  
Date Received01/27/2010
Decision Date 11/24/2010
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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