FDA 510(k) Application Details - K971640

Device Classification Name	Lead, Atomic Absorption   More FDA Info for this Device
510(K) Number	K971640
Device Name	Lead, Atomic Absorption
Applicant	ESA, INC. 22 ALPHA RD. CHELMSFORD, MA 01824-4171 US Other 510(k) Applications for this Company
Contact	JAMES MAYOL Other 510(k) Applications for this Contact
Regulation Number	862.3550   More FDA Info for this Regulation Number
Classification Product Code	DOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/1997
Decision Date	09/09/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review