FDA 510(k) Application Details - K062697

Device Classification Name Mesh, Surgical, Polymeric

  More FDA Info for this Device
510(K) Number K062697
Device Name Mesh, Surgical, Polymeric
Applicant COOK BIOTECH, INC.
1425 INNOVATION PLACE
WEST LAFAYETTE, IN 47906-1000 US
Other 510(k) Applications for this Company
Contact MARY A FADERAN
Other 510(k) Applications for this Contact
Regulation Number 878.3300

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

  More FDA Info for this Product Code
Date Received 09/11/2006
Decision Date 10/13/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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