FDA 510(k) Application Details - K191268

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K191268
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	Teleflex Medical Incorporated 375 Forbes Boulevard Mansfield, MA 02048 US Other 510(k) Applications for this Company
Contact	Andrea Curria 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	05/13/2019
Decision Date	06/11/2019
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
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