FDA 510(k) Application Details - K152795

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyamide

  More FDA Info for this Device
510(K) Number K152795
Device Name Suture, Nonabsorbable, Synthetic, Polyamide
Applicant RIVERPOINT MEDICAL
825 NE 25TH AVENUE
PORTLAND, OR 97232 US
Other 510(k) Applications for this Company
Contact Edwin Anderson
Other 510(k) Applications for this Contact
Regulation Number 878.5020

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

  More FDA Info for this Product Code
Date Received 09/28/2015
Decision Date 10/28/2015
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