FDA 510(k) Application Details - K212603

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyamide   More FDA Info for this Device
510(K) Number	K212603
Device Name	Suture, Nonabsorbable, Synthetic, Polyamide
Applicant	Shandong Haidike Medical Product Co., Ltd. Tianfu Road, Dongcheng District, Shan County Heze 274300 CN Other 510(k) Applications for this Company
Contact	Lili Xu Other 510(k) Applications for this Contact
Regulation Number	878.5020   More FDA Info for this Regulation Number
Classification Product Code	GAR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2021
Decision Date	12/22/2021
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