FDA 510(k) Application Details - K242937

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K242937
Device Name	Gown, Surgical
Applicant	DAE MYUNG CHEMICAL CO., LTD. (VIETNAM) Lot CI.II-7a and Lot CI.II-7a', Street No. 5, Long Thanh Industrial Zone, Tam An Ward Long Thanh 810000 VN Other 510(k) Applications for this Company
Contact	Tri Do Minh Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2024
Decision Date	05/05/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review