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FDA 510(k) Application Details - K040569
Device Classification Name
Permanent Pacemaker Electrode
More FDA Info for this Device
510(K) Number
K040569
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
03/04/2004
Decision Date
04/07/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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