FDA 510(k) Application Details - K230311

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K230311
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	Threadstone L.L.C. 1035 Benfield Blvd, Suite H Millersville, MD 21108 US Other 510(k) Applications for this Company
Contact	Jeremy Clark 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	02/03/2023
Decision Date	11/24/2023
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