FDA 510(k) Application Details - K014195

Device Classification Name	Fluorometer, Lead (Dedicated Instruments)   More FDA Info for this Device
510(K) Number	K014195
Device Name	Fluorometer, Lead (Dedicated Instruments)
Applicant	BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 US Other 510(k) Applications for this Company
Contact	MARK MURPHY Other 510(k) Applications for this Contact
Regulation Number	862.3550   More FDA Info for this Regulation Number
Classification Product Code	DOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2001
Decision Date	03/19/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review