Device Classification Name |
sampler, amniotic fluid (amniocentesis tray)
|
510(k) Number |
K844558 |
Device Name |
UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE |
Applicant |
UNIVERSAL MEDICAL INSTRUMENT CORP. |
POST OFFICE BOX 100 |
BALLSTON SPA,
NY
12020
|
|
Applicant Contact |
CHARLES M COPPERBER |
Correspondent |
UNIVERSAL MEDICAL INSTRUMENT CORP. |
POST OFFICE BOX 100 |
BALLSTON SPA,
NY
12020
|
|
Correspondent Contact |
CHARLES M COPPERBER |
Regulation Number | 884.1550
|
Classification Product Code |
|
Date Received | 11/21/1984 |
Decision Date | 01/31/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|