Device Classification Name |
pessary, vaginal
|
510(k) Number |
K032644 |
Device Name |
KOLPEXIN SPHERE |
Applicant |
ADAMED LTD. |
3432 BROOKSHIRE DR. |
PLANO,
TX
75075
|
|
Applicant Contact |
NORMAN I BRUCKNER |
Correspondent |
ADAMED LTD. |
3432 BROOKSHIRE DR. |
PLANO,
TX
75075
|
|
Correspondent Contact |
NORMAN I BRUCKNER |
Regulation Number | 884.3575
|
Classification Product Code |
|
Date Received | 08/27/2003 |
Decision Date | 05/28/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|