FDA 510(k) Application Details - K031799

Device Classification Name Device, Pasteurization, Hot Water

  More FDA Info for this Device
510(K) Number K031799
Device Name Device, Pasteurization, Hot Water
Applicant MIELE, INC.
9 INDEPENDENCE WAY
PRINCETON, NJ 08540 US
Other 510(k) Applications for this Company
Contact STEVE POLINSKI
Other 510(k) Applications for this Contact
Regulation Number 880.6991

  More FDA Info for this Regulation Number
Classification Product Code LDS
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/10/2003
Decision Date 11/12/2003
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 N
Expedited Review



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