FDA 510(k) Application Details - K123987

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K123987
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	INNOVATIVE MEDICAL TECHNOLOGIES, INC. 15059 CEDAR ST. LEAWOOD, KS 66224 US Other 510(k) Applications for this Company
Contact	BRAD BROWN Other 510(k) Applications for this Contact
Regulation Number	862.1675   More FDA Info for this Regulation Number
Classification Product Code	JKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2012
Decision Date	08/27/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review