FDA 510(k) Application Details - K011826

Device Classification Name	Generator, Pulse, Pacemaker, External Programmable   More FDA Info for this Device
510(K) Number	K011826
Device Name	Generator, Pulse, Pacemaker, External Programmable
Applicant	MICROPACE PTY. LTD. 571 CANTERBURY RD. CAMPSIE, N.S.W. 2194 AU Other 510(k) Applications for this Company
Contact	MICHAEL CEJNAR Other 510(k) Applications for this Contact
Regulation Number	870.1750   More FDA Info for this Regulation Number
Classification Product Code	JOQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2001
Decision Date	01/24/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review