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FDA 510(k) Application Details - K073104
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
510(K) Number
K073104
Device Name
Electrode, Electrocardiograph
Applicant
LEONHARD LANG GMBH
P.O. BOX 560
STILLWATER, MN 55082-0560 US
Other 510(k) Applications for this Company
Contact
ELAINE DUNCAN
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
11/02/2007
Decision Date
11/16/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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