FDA 510(k) Application Details - K193530

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polypropylene   More FDA Info for this Device
510(K) Number	K193530
Device Name	Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant	Teleflex Medical 3015 Carrington Mill Blvd Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Robin Haden Other 510(k) Applications for this Contact
Regulation Number	878.5010   More FDA Info for this Regulation Number
Classification Product Code	GAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2019
Decision Date	03/19/2020
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