Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number |
K040238 |
Device Name |
SOFTSEAL HSG CATHETER |
Applicant |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
1705 DABNEY RD. |
RICHMOND,
VA
23230
|
|
Applicant Contact |
AL MUZZAMMEL |
Correspondent |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
1705 DABNEY RD. |
RICHMOND,
VA
23230
|
|
Correspondent Contact |
AL MUZZAMMEL |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 01/26/2004 |
Decision Date | 06/22/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|