FDA 510(k) Application Details - K013683

Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene

  More FDA Info for this Device
510(K) Number K013683
Device Name Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant ABBOTT VASCULAR INC.
400 Saginaw Drive
Redwood City, CA 94063 US
Other 510(k) Applications for this Company
Contact PATTY HEVEY
Other 510(k) Applications for this Contact
Regulation Number 878.5010

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

  More FDA Info for this Product Code
Date Received 11/07/2001
Decision Date 12/06/2001
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