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FDA 510(k) Application Details - K013339
Device Classification Name
Permanent Pacemaker Electrode
More FDA Info for this Device
510(K) Number
K013339
Device Name
Permanent Pacemaker Electrode
Applicant
Oscor Inc.
3816 DE SOTO BLVD.
PALM HARBOR, FL 34683 US
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Contact
MILA DOSKOCIL
Other 510(k) Applications for this Contact
Regulation Number
870.3680
More FDA Info for this Regulation Number
Classification Product Code
DTB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/09/2001
Decision Date
11/08/2001
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Special
Reviewed By Third Party
N
Expedited Review
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