FDA 510(k) Application Details - K031164

Device Classification Name	Pacemaker Lead Adaptor   More FDA Info for this Device
510(K) Number	K031164
Device Name	Pacemaker Lead Adaptor
Applicant	Oscor Inc. 3816 DE SOTO BLVD. PALM HARBOR, FL 34683 US Other 510(k) Applications for this Company
Contact	MILA DOCKOCIL Other 510(k) Applications for this Contact
Regulation Number	870.3620   More FDA Info for this Regulation Number
Classification Product Code	DTD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2003
Decision Date	06/19/2003
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