FDA.report

510(k) K854725

Device
Hurwitz Amniocentesis Needle
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K854725
Product code
HIO
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-17
Date received
1985-11-22
Regulation
884.1550
Classification name
Sampler, Amniotic Fluid (Amniocentesis Tray)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Third party reviewed
N

Related Records

Applicant Contact

Contact
RUSSELL J.ARNSBERGER
Address
Mack Centre Dr. P.O.Box 2224 Paramus NJ US 07652 07652

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HIO

510(k)DeviceApplicantDecision date
K960203G.E. STERILE AMNIOCENTESIS TRAYGE Medical Systems1996-03-14
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
K850632PMS AMNIOCENTESIS TRAY/KITProfessional Medical Services1985-05-22