FDA 510(k) Application Details - K061892

Device Classification Name Mesh, Surgical

  More FDA Info for this Device
510(K) Number K061892
Device Name Mesh, Surgical
Applicant CRYOLIFE, INC.
1655 ROBERTS BLVD., N.W.
KENNESAW, GA 30144 US
Other 510(k) Applications for this Company
Contact JOHN D FERROS
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 07/03/2006
Decision Date 11/22/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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