Device Classification Name |
aspirator, endometrial
|
510(k) Number |
K903002 |
Device Name |
PROBET (TM) |
Applicant |
GYNOPHARMA, INC. |
C/O ELLIS PHARM CONSULTING INC |
913 STATE ROAD |
PRINCETON,
NJ
08540
|
|
Applicant Contact |
LEVI ELLIS |
Correspondent |
GYNOPHARMA, INC. |
C/O ELLIS PHARM CONSULTING INC |
913 STATE ROAD |
PRINCETON,
NJ
08540
|
|
Correspondent Contact |
LEVI ELLIS |
Regulation Number | 884.1060
|
Classification Product Code |
|
Date Received | 07/09/1990 |
Decision Date | 04/05/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|