FDA 510(k) Application Details - K230135

Device Classification Name	Gown, Isolation, Surgical   More FDA Info for this Device
510(K) Number	K230135
Device Name	Gown, Isolation, Surgical
Applicant	Copioumed International Inc. 16F-4, No.1, Fuxing N. Rd., Songshan Dist., Taipei City 105 TW Other 510(k) Applications for this Company
Contact	James Liu 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	01/18/2023
Decision Date	10/04/2023
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