FDA 510(k) Application Details - K083870

Device Classification Name Dressing, Wound, Drug

  More FDA Info for this Device
510(K) Number K083870
Device Name Dressing, Wound, Drug
Applicant EXCITON TECHNOLOGIES INC.
6605 HRONTARIO STREET
MISSISSAUGA, ONTARIO L5T O3A CA
Other 510(k) Applications for this Company
Contact SANDRA REIS
Other 510(k) Applications for this Contact
Regulation Number 000.0000

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

  More FDA Info for this Product Code
Date Received 12/29/2008
Decision Date 07/30/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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