FDA 510(k) Application Details - K102158

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K102158
Device Name	Wrap, Sterilization
Applicant	SIGMA MEDICAL SUPPLIES CORP. # 15-2, LN 26, MINEYUAN 1ST RD LINGYA DISTRICT KAOHSIUNG 802 TW Other 510(k) Applications for this Company
Contact	UTA SHIH 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	07/30/2010
Decision Date	08/02/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review