FDA 510(k) Application Details - K071111

Device Classification Name Suture, Nonabsorbable, Silk

  More FDA Info for this Device
510(K) Number K071111
Device Name Suture, Nonabsorbable, Silk
Applicant ARROW INTL., INC.
2400 BERNVILLE RD.
READING, PA 19605 US
Other 510(k) Applications for this Company
Contact KARL J NITTINGER
Other 510(k) Applications for this Contact
Regulation Number 878.5030

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

  More FDA Info for this Product Code
Date Received 04/20/2007
Decision Date 07/17/2007
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