FDA 510(k) Application Details - K212464

Device Classification Name	More FDA Info for this Device
510(K) Number	K212464
Device Name	Dukal Corporation AAMI Level 4 Open-Back Protective Gown
Applicant	Dukal Corporation 2 Fleetwood Court Ronkonkoma, NY 11779 US Other 510(k) Applications for this Company
Contact	Megan Quevedo 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	08/06/2021
Decision Date	03/30/2022
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