FDA 510(k) Application Details - K970497

Device Classification Name	Pulse-Generator, Pacemaker, External   More FDA Info for this Device
510(K) Number	K970497
Device Name	Pulse-Generator, Pacemaker, External
Applicant	SULZER OSCOR, INC. 3816 DeSoto 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	870.3600   More FDA Info for this Regulation Number
Classification Product Code	DTE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/1997
Decision Date	06/04/1997
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