FDA 510(k) Application Details - K112800

Device Classification Name	More FDA Info for this Device
510(K) Number	K112800
Device Name	SUNTOUCH TOPICAL HEMOSTATIC DRESSING
Applicant	HUIZHOU FORYOU MEDICAL DEVICES CO, LTD 5 CAREY STREET PENNINGTON, NJ 08534 US Other 510(k) Applications for this Company
Contact	CHENGYU SHEN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2011
Decision Date	05/23/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review