FDA 510(k) Application Details - DEN130016

Device Classification Name

  More FDA Info for this Device
510(K) Number DEN130016
Device Name XSTAT
Applicant REVMEDX, INC.
555 13TH STREET NW
WASHINGTON, DC 20004 US
Other 510(k) Applications for this Company
Contact JOHN J SMITH
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 01/30/2013
Decision Date 04/03/2014
Decision DENG -
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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