FDA 510(k) Application Details - K210675

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K210675
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	Winter Innovations, Inc. 2450 EJ Chapman Drive, Suite 114 Knoxville, TN 37996 US Other 510(k) Applications for this Company
Contact	Lia Winter 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	03/05/2021
Decision Date	05/03/2021
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