FDA 510(k) Application Details - K134033

Device Classification Name Mesh, Surgical

  More FDA Info for this Device
510(K) Number K134033
Device Name Mesh, Surgical
Applicant MIROMATRIX MEDICAL INC.
400 N. WASHINGTON ST., STE 100
ALEXANDRIA, VA 22314 US
Other 510(k) Applications for this Company
Contact STEPHEN RHODES
Other 510(k) Applications for this Contact
Regulation Number 878.3300

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

  More FDA Info for this Product Code
Date Received 12/31/2013
Decision Date 03/31/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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