FDA 510(k) Application Details - K993787

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K993787
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	OSBORN GROUP, INC. 14901 WEST 117TH ST. OLATHE, KS 66062 US Other 510(k) Applications for this Company
Contact	GILBERT P BOURK III 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	11/09/1999
Decision Date	04/14/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review