FDA 510(k) Application Details - K080684

Device Classification Name Suture, Nonabsorbable, Silk

  More FDA Info for this Device
510(K) Number K080684
Device Name Suture, Nonabsorbable, Silk
Applicant FOOSIN MEDICAL SUPPLIES INC.
SUITE 8D, ZHONGXIN ZHONGSHAN
MANSION, NO. 19 LANE 999
ZHONG SHAN, SHANGHAI 20030 CN
Other 510(k) Applications for this Company
Contact Diana Hong
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 03/10/2008
Decision Date 06/09/2008
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