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FDA 510(k) Application Details - K040784
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
510(K) Number
K040784
Device Name
Electrode, Electrocardiograph
Applicant
BIO PROTECH, INC.
1676 VILLAGE GREEN SUITE A
CROFTON, MD 21114 US
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Contact
E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number
870.2360
More FDA Info for this Regulation Number
Classification Product Code
DRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/29/2004
Decision Date
04/07/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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