FDA 510(k) Application Details - K201351

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K201351
Device Name	Gown, Surgical
Applicant	Elevate Textiles 22 American Street Mt. Holly, NC 28210 US Other 510(k) Applications for this Company
Contact	Nathaniel Terry 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	05/21/2020
Decision Date	03/11/2022
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