FDA 510(k) Application Details - K142810

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

  More FDA Info for this Device
510(K) Number K142810
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant FOOSIN MEDICAL SUPPLIES INC.LTD
No.20, Xingshan Road
Weihai Torch Hi-tech Science Park
WEIHAI 264210 CN
Other 510(k) Applications for this Company
Contact Suxia Zhao
Other 510(k) Applications for this Contact
Regulation Number 878.4493

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

  More FDA Info for this Product Code
Date Received 09/29/2014
Decision Date 11/14/2014
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