FDA 510(k) Application Details - K040232

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

  More FDA Info for this Device
510(K) Number K040232
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant LSI SOLUTIONS
7796 VICTOR-MENDON RD.
VICTOR, NY 14564 US
Other 510(k) Applications for this Company
Contact CHRISTOPHER A KLACZYK
Other 510(k) Applications for this Contact
Regulation Number 878.5000

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

  More FDA Info for this Product Code
Date Received 02/02/2004
Decision Date 03/01/2004
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