FDA 510(k) Application Details - K970419

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K970419
Device Name	Syringe, Piston
Applicant	DAXOR CORPORATION 312 TROSSACHS LN. KNOXVILLE, TN 37922-3421 US Other 510(k) Applications for this Company
Contact	RONALD H BALDRY Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/1997
Decision Date	12/22/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review