FDA 510(k) Application Details - K232355

Device Classification Name	Suture, Nonabsorbable, Silk   More FDA Info for this Device
510(K) Number	K232355
Device Name	Suture, Nonabsorbable, Silk
Applicant	Shandong Haidike Medical Product Co., Ltd. Tianfu Road, Dongcheng District, Shan County Heze 274300 CN Other 510(k) Applications for this Company
Contact	Yan Wang Other 510(k) Applications for this Contact
Regulation Number	878.5030   More FDA Info for this Regulation Number
Classification Product Code	GAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2023
Decision Date	01/16/2024
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