FDA 510(k) Application Details - K180661

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K180661
Device Name	Wrap, Sterilization
Applicant	Sigma Medical Supplies Corp. 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	Mason Huang 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	03/14/2018
Decision Date	06/05/2018
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