FDA 510(k) Application Details - K231277

Device Classification Name	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene   More FDA Info for this Device
510(K) Number	K231277
Device Name	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Applicant	DuraStat LLC 1101 E 6th St Unit B Austin, TX 78702 US Other 510(k) Applications for this Company
Contact	Adam Azzara Other 510(k) Applications for this Contact
Regulation Number	878.5035   More FDA Info for this Regulation Number
Classification Product Code	NBY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2023
Decision Date	11/09/2023
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