Device Classification Name |
sampler, amniotic fluid (amniocentesis tray)
|
510(k) Number |
K894031 |
Device Name |
PHARMASEAL GENETIC AMNIOCENTESIS TRAY |
Applicant |
BAXTER HEALTHCARE CORP. |
27200 NORTH TOURNEY RD. |
P.O. BOX 5900 |
VALENCIA,
CA
91355 -8900
|
|
Applicant Contact |
T MERRICK |
Correspondent |
BAXTER HEALTHCARE CORP. |
27200 NORTH TOURNEY RD. |
P.O. BOX 5900 |
VALENCIA,
CA
91355 -8900
|
|
Correspondent Contact |
T MERRICK |
Regulation Number | 884.1550
|
Classification Product Code |
|
Date Received | 06/06/1989 |
Decision Date | 08/04/1989 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|