Device Classification Name |
Sampler, Amniotic Fluid (Amniocentesis Tray)
|
510(k) Number |
K761230 |
Device Name |
AMMOCENTESIS TRAY (KIT) |
Applicant |
PHARMASEAL DIV., BAXTER HEALTHCARE CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
PHARMASEAL DIV., BAXTER HEALTHCARE CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 884.1550
|
Classification Product Code |
|
Date Received | 12/10/1976 |
Decision Date | 12/17/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|