FDA 510(k) Application Details - K954142

Device Classification Name Sterilizer, Steam

  More FDA Info for this Device
510(K) Number K954142
Device Name Sterilizer, Steam
Applicant ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE, CA 92618 US
Other 510(k) Applications for this Company
Contact KEVIN CORRIGAN
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 09/01/1995
Decision Date 06/06/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact