FDA 510(k) Application Details - K193209

Device Classification Name	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile   More FDA Info for this Device
510(K) Number	K193209
Device Name	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
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	878.4495   More FDA Info for this Regulation Number
Classification Product Code	GAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2019
Decision Date	02/19/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review