FDA 510(k) Application Details - K033538

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K033538
Device Name	Sterilizer, Steam
Applicant	SAUTER AG ZELGSTRASSE 8 SULGEN TG CH-8583 CH Other 510(k) Applications for this Company
Contact	HANS STADLER 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	11/10/2003
Decision Date	02/02/2004
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	Y
Expedited Review