FDA 510(k) Application Details - K960203

Device Classification Name	Sampler, Amniotic Fluid (Amniocentesis Tray)   More FDA Info for this Device
510(K) Number	K960203
Device Name	Sampler, Amniotic Fluid (Amniocentesis Tray)
Applicant	GE MEDICAL SYSTEMS 1247 FLORDIA AVE. PALM HARBOR, FL 34683 US Other 510(k) Applications for this Company
Contact	PATRICK J LAMB Other 510(k) Applications for this Contact
Regulation Number	884.1550   More FDA Info for this Regulation Number
Classification Product Code	HIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/1996
Decision Date	03/14/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review