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FDA 510(k) Application Details - K981964
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
510(K) Number
K981964
Device Name
Electrode, Electrocardiograph
Applicant
GRAPHIC CONTROLS CORP.
PO BOX 1274
189 VAN RENSSELAER STREET
BUFFALO, NY 14240 US
Other 510(k) Applications for this Company
Contact
SUSAN KRASNY
Other 510(k) Applications for this Contact
Regulation Number
870.2360
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Classification Product Code
DRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/04/1998
Decision Date
11/13/1998
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
N
Expedited Review
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