FDA 510(k) Application Details - K210414

Device Classification Name	Gown, Isolation, Surgical   More FDA Info for this Device
510(K) Number	K210414
Device Name	Gown, Isolation, Surgical
Applicant	Medtecs (Taiwan) Corp. 11F., No. 9, Songgao Road, Xinyi Dist. Taipei City 11073 TW Other 510(k) Applications for this Company
Contact	William Yang 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	02/11/2021
Decision Date	10/21/2022
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