FDA 510(k) Application Details - K181633

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K181633
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	Musculoskeletal Transplant Foundation 125 May Street Edison, NJ 08837 US Other 510(k) Applications for this Company
Contact	Katrina Carroll 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	06/20/2018
Decision Date	03/15/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review