FDA 510(k) Application Details - K963579

Device Classification Name	Generator, Pulse, Pacemaker, External Programmable   More FDA Info for this Device
510(K) Number	K963579
Device Name	Generator, Pulse, Pacemaker, External Programmable
Applicant	RADIONICS, INC. 22 TERRY AVE. BURLINGTON, MA 01803-2516 US Other 510(k) Applications for this Company
Contact	AMY J LAFORTE, PH.D 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	09/06/1996
Decision Date	11/08/1996
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