FDA 510(k) Application Details - K243431

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K243431
Device Name	Wrap, Sterilization
Applicant	Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. No. 11, Sec. 2, Ligong 1st Rd, Wujie Township Yilan County 26841 TW Other 510(k) Applications for this Company
Contact	Kristy Lee 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	11/05/2024
Decision Date	02/21/2025
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