Device Classification Name |
spatula, cervical, cytological
|
510(k) Number |
K911327 |
Device Name |
CELL SWEEP |
Applicant |
REZA S MOHAJER, M.D. C/O KRASS & YOUNG |
C/O KRASS & YOUNG LAW OFFICES |
3001 W. BIG BEAVER RD STE 624 |
TROY,
MI
48084
|
|
Applicant Contact |
RONALD W CITKOWSKI |
Correspondent |
REZA S MOHAJER, M.D. C/O KRASS & YOUNG |
C/O KRASS & YOUNG LAW OFFICES |
3001 W. BIG BEAVER RD STE 624 |
TROY,
MI
48084
|
|
Correspondent Contact |
RONALD W CITKOWSKI |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 03/26/1991 |
Decision Date | 05/21/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|