FDA 510(k) Application Details - K021160

Device Classification Name Mesh, Surgical

  More FDA Info for this Device
510(K) Number K021160
Device Name Mesh, Surgical
Applicant CARBON MEDICAL TECHNOLOGIES, INC.
1290 HAMMOND RD.
ST. PAUL, MN 55110 US
Other 510(k) Applications for this Company
Contact KAREN E PETERSON
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 04/11/2002
Decision Date 06/12/2002
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