FDA.reportPublic FDA data

510(k) K960203

Device
G.e. Sterile Amniocentesis Tray
Applicant
GE MEDICAL SYSTEMS
510(k) number
K960203
Product code
HIO
Decision
Substantially Equivalent (SESE)
Decision date
1996-03-14
Date received
1996-01-16
Regulation
884.1550
Classification name
Sampler, Amniotic Fluid (Amniocentesis Tray)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PATRICK J LAMB
Address
1247 Flordia Ave. Palm Harbor FL US 34683 34683

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HIO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K955679RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAYContour Fabricators of Florida, Inc.1996-03-12
K914419AMNIOTEST(TM)Pro-Lab, Inc.1993-09-01
K922960VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLECameo, Inc.1992-11-05
K921738SONO-VU US(TM), MODIFICATIONE-Z-Em, Inc.1992-04-27
K915863MEGA AMNIOCENTESIS KITMega Medical, Inc.1992-03-30
K904583SONO-VU US(TM)E-Z-Em, Inc.1991-06-24
K901643ISOFLO(TM) AMNIOCENTESIS TRAYHealthdyne Cardiovascular, Inc.1990-07-25
K900021PERCU-SET(TM)E-Z-Em, Inc.1990-03-29
K896031AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)Concord/Portex1990-01-12
K894031PHARMASEAL GENETIC AMNIOCENTESIS TRAYBaxter Healthcare Corp1989-08-04
K892846ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLECook Ob/Gyn1989-07-14
K890463ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAYCritical Specialties, Inc.1989-04-07
K862365NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURESwemed Laboratories, Inc.1986-07-07
K854725HURWITZ AMNIOCENTESIS NEEDLEBd Becton Dickinson Vacutainer Systems Preanalytic1986-03-17
K850632PMS AMNIOCENTESIS TRAY/KITProfessional Medical Services1985-05-22