FDA 510(k) Application Details - K203081

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyester   More FDA Info for this Device
510(K) Number	K203081
Device Name	Suture, Nonabsorbable, Synthetic, Polyester
Applicant	LSI Solutions 7796 Victor-Mendon Rd. Victor, NY 14564 US Other 510(k) Applications for this Company
Contact	Christopher B Miller Other 510(k) Applications for this Contact
Regulation Number	878.5000   More FDA Info for this Regulation Number
Classification Product Code	GAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/2020
Decision Date	11/24/2020
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