FDA 510(k) Application Details - K210785

Device Classification Name	Gown, Isolation, Surgical   More FDA Info for this Device
510(K) Number	K210785
Device Name	Gown, Isolation, Surgical
Applicant	Chongqing Litai Fashion Group Limited Company Building D7-1, Chongqing China Textile & Garment City Project, Maliu Yanjiang Development Zone, Chongqing CN Other 510(k) Applications for this Company
Contact	David Ni Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2021
Decision Date	11/13/2021
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