FDA 510(k) Application Details - K970388

Device Classification Name	Pacemaker Lead Adaptor   More FDA Info for this Device
510(K) Number	K970388
Device Name	Pacemaker Lead Adaptor
Applicant	BIOTRONIK, INC. 6024 JEAN ROAD LAKE OSWEGO, OR 97035 US Other 510(k) Applications for this Company
Contact	Joseph J Schwoebel 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	02/03/1997
Decision Date	08/14/1997
Decision	PT - Substantially Equivalent - Subject to Tracking & PMS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review