FDA 510(k) Application Details - K212888

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyamide   More FDA Info for this Device
510(K) Number	K212888
Device Name	Suture, Nonabsorbable, Synthetic, Polyamide
Applicant	Antarma LLC dba Golnit Sutures 276 5th Ave., Suite 704 New York, NY 10001 US Other 510(k) Applications for this Company
Contact	Armine Badalyan 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	09/10/2021
Decision Date	03/31/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review