FDA 510(k) Application Details - K202462

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K202462
Device Name	Wrap, Sterilization
Applicant	Sigma Medical Supplies Corporation NO.34, Ding-Ping Road, Rui Fang Industrial Park, Rui Fang Dist. New Taipei City 224 TW Other 510(k) Applications for this Company
Contact	Ethan Lin Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	FRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2020
Decision Date	04/23/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review