Device Classification Name |
sampler, amniotic fluid (amniocentesis tray)
|
510(k) Number |
K850632 |
Device Name |
PMS AMNIOCENTESIS TRAY/KIT |
Applicant |
PROFESSIONAL MEDICAL SERVICES |
P.O. BOX 250 |
700 WEST 200 NORTH |
NORTH SALT LAKE,
UT
84054
|
|
Applicant Contact |
JAMES E WILLIAMS |
Correspondent |
PROFESSIONAL MEDICAL SERVICES |
P.O. BOX 250 |
700 WEST 200 NORTH |
NORTH SALT LAKE,
UT
84054
|
|
Correspondent Contact |
JAMES E WILLIAMS |
Regulation Number | 884.1550
|
Classification Product Code |
|
Date Received | 02/19/1985 |
Decision Date | 05/22/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|