FDA 510(k) Application Details - K964332

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K964332
Device Name	Sterilizer, Steam
Applicant	AMSCO INTL., INC. 2424 W 23RD STREET-AMSCO-620 ERIE, PA 16514 US Other 510(k) Applications for this Company
Contact	PAUL ZAMECNIK 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	10/30/1996
Decision Date	06/01/1998
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