FDA 510(k) Application Details - K242689

Device Classification Name	More FDA Info for this Device
510(K) Number	K242689
Device Name	AAMI Level 4 Protective; Gown
Applicant	AZAC Group 17870 Castleton St Suite 121 City of Industry, CA 91748 US Other 510(k) Applications for this Company
Contact	Yen Ping Shan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2024
Decision Date	01/13/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review