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FDA 510(k) Application Details - K973727
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
510(K) Number
K973727
Device Name
Electrode, Electrocardiograph
Applicant
DON TAY INDUSTRIES
2383 S. 16ND ST.
NEW BERLIN, WI 53151 US
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Contact
EDWARD ARNDT
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
09/30/1997
Decision Date
12/19/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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