Device Classification Name |
sampler, amniotic fluid (amniocentesis tray)
|
510(k) Number |
K854725 |
Device Name |
HURWITZ AMNIOCENTESIS NEEDLE |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
MACK CENTRE DR. |
P.O.BOX 2224 |
PARAMUS,
NJ
07652
|
|
Applicant Contact |
RUSSELL J.ARNSBERGER |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
MACK CENTRE DR. |
P.O.BOX 2224 |
PARAMUS,
NJ
07652
|
|
Correspondent Contact |
RUSSELL J.ARNSBERGER |
Regulation Number | 884.1550
|
Classification Product Code |
|
Date Received | 11/22/1985 |
Decision Date | 03/17/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|