FDA 510(k) Application Details - K120532

Device Classification Name	More FDA Info for this Device
510(K) Number	K120532
Device Name	GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM
Applicant	GETINGE SOURCING LLC 1777 EAST HENRIETTA RD. ROCHESTER, NY 14623-3133 US Other 510(k) Applications for this Company
Contact	BARB SMITH Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2012
Decision Date	05/02/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review