FDA 510(k) Application Details - K022067

Device Classification Name	Fab, Rhodamine, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K022067
Device Name	Fab, Rhodamine, Antigen, Antiserum, Control
Applicant	BOSTON SCIENTIFIC 2710 ORCHARD PKWY. SAN JOSE, CA 95134 US Other 510(k) Applications for this Company
Contact	ANDREA L RUTH Other 510(k) Applications for this Contact
Regulation Number	866.5520   More FDA Info for this Regulation Number
Classification Product Code	DBY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2002
Decision Date	09/11/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review