FDA 510(k) Application Details - K050664

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K050664
Device Name	Indicator, Biological Sterilization Process
Applicant	GETINGE USA, INC 1777 EAST HENRIETTA RD. ROCHESTER, NY 14623-3133 US Other 510(k) Applications for this Company
Contact	BARD SMITH Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	FRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2005
Decision Date	04/07/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review