FDA 510(k) Application Details - K192088

Device Classification Name	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene   More FDA Info for this Device
510(K) Number	K192088
Device Name	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
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	878.5035   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	08/05/2019
Decision Date	09/04/2019
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