FDA 510(k) Application Details - K231163

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K231163
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	Paul Vagts 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	04/24/2023
Decision Date	01/05/2024
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