Device Classification Name |
sampler, amniotic fluid (amniocentesis tray)
|
510(k) Number |
K922960 |
Device Name |
VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE |
Applicant |
CAMEO, INC. |
P.O. BOX 525 |
TOLEDO,
OH
43693
|
|
Applicant Contact |
ROBERT FEDYNICH |
Correspondent |
CAMEO, INC. |
P.O. BOX 525 |
TOLEDO,
OH
43693
|
|
Correspondent Contact |
ROBERT FEDYNICH |
Regulation Number | 884.1550
|
Classification Product Code |
|
Date Received | 06/18/1992 |
Decision Date | 11/05/1992 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|