FDA 510(k) Application Details - K944036

Device Classification Name Sterilizer, Steam

  More FDA Info for this Device
510(K) Number K944036
Device Name Sterilizer, Steam
Applicant SCICAN
1440 DON MILLS RD.
TORONTO, ONTARIO M3B 3P9 CA
Other 510(k) Applications for this Company
Contact NEIL MCPHAIL
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 08/18/1994
Decision Date 10/02/1996
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



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