FDA 510(k) Application Details - K972969

Device Classification Name	Tube, Collection, Capillary Blood   More FDA Info for this Device
510(K) Number	K972969
Device Name	Tube, Collection, Capillary Blood
Applicant	INNOVATIVE MEDICAL TECHNOLOGIES, INC. 10661 RENE ST. LENEXA, KS 66215 US Other 510(k) Applications for this Company
Contact	BRADLEY V BROWN Other 510(k) Applications for this Contact
Regulation Number	864.6150   More FDA Info for this Regulation Number
Classification Product Code	GIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/1997
Decision Date	09/22/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review