FDA 510(k) Application Details - K112341

Device Classification Name	More FDA Info for this Device
510(K) Number	K112341
Device Name	SNAP WOUND CARE SYSTEM
Applicant	SPIRACUR, INC. 755 N. MATHILDA AVENUE SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	SARAH CANIO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OKO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2011
Decision Date	08/29/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review