FDA 510(k) Application Details - K241565

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K241565
Device Name	Wrap, Sterilization
Applicant	Anqing Clean Dental Instrument Technology Co., Ltd. Floor 2, D4-A, Jiabao Industrial Park.Yangtze River Bridge Economic Development Zone Anqing 246000 CN Other 510(k) Applications for this Company
Contact	Wu Yiming Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	FRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2024
Decision Date	02/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review