FDA 510(k) Application Details - K970907

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K970907
Device Name	Sterilizer, Steam
Applicant	GETINGE/CASTLE, INC. 1777 EAST HENRIETTA RD. ROCHESTER, NY 14623-3133 US Other 510(k) Applications for this Company
Contact	MICHAEL J PALLADINO Other 510(k) Applications for this Contact
Regulation Number	880.6880   More FDA Info for this Regulation Number
Classification Product Code	FLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/1997
Decision Date	11/12/1997
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	Y
Expedited Review