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 Other 510(k) Applications for this Company
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