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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
No

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), Device, Applicant table
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