FDA 510(k) Application Details - K143463

Device Classification Name	Pacemaker Lead Adaptor   More FDA Info for this Device
510(K) Number	K143463
Device Name	Pacemaker Lead Adaptor
Applicant	Oscor Inc. 3816 De Soto Boulevard Palm Harbor, FL 34683 US Other 510(k) Applications for this Company
Contact	Dorit Segal 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	12/04/2014
Decision Date	03/19/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review