FDA 510(k) Application Details - K092364

Device Classification Name	Magnet, Test, Pacemaker   More FDA Info for this Device
510(K) Number	K092364
Device Name	Magnet, Test, Pacemaker
Applicant	CYBERONICS, INC. 100 CYBERONICS BLVD. HOUSTON, TX 77058-2017 US Other 510(k) Applications for this Company
Contact	KAREN STUEBER Other 510(k) Applications for this Contact
Regulation Number	870.3690   More FDA Info for this Regulation Number
Classification Product Code	DTG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2009
Decision Date	11/03/2009
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