FDA 510(k) Application Details - K011980

Device Classification Name	Pulse-Generator, Pacemaker, External   More FDA Info for this Device
510(K) Number	K011980
Device Name	Pulse-Generator, Pacemaker, External
Applicant	PACE MEDICAL 391 TOTTEN POND RD. WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	ROBERT C MACE 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	06/25/2001
Decision Date	09/12/2001
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