FDA 510(k) Application Details - K123006

Device Classification Name	More FDA Info for this Device
510(K) Number	K123006
Device Name	AIR BARRIER SYSTEM (ABS)
Applicant	NIMBIC SYSTEMS, INC 11874 SOUTH EVELYN CIRCLE HOUSTON, TX 77477-3404 US Other 510(k) Applications for this Company
Contact	HARVEY KNAUSS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2012
Decision Date	12/20/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review