FDA 510(k) Application Details - K170842

Device Classification Name	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene   More FDA Info for this Device
510(K) Number	K170842
Device Name	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Applicant	Foosin Medical Supplies Inc., Ltd. No.20, Xingshan Road, Weihai Torch Hi-tech Science Park Weihai 264210 CN Other 510(k) Applications for this Company
Contact	Zhipeng Yang Other 510(k) Applications for this Contact
Regulation Number	878.5035   More FDA Info for this Regulation Number
Classification Product Code	NBY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2017
Decision Date	07/31/2017
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