FDA 510(k) Application Details - K190817

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

  More FDA Info for this Device
510(K) Number K190817
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant Riverpoint Medical
825 NE 25th Ave.
Portland, OR 97232 US
Other 510(k) Applications for this Company
Contact Edwin Anderson
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 04/01/2019
Decision Date 05/01/2019
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