Device Classification Name |
Dilator, Cervical, Hygroscopic-Laminaria
|
510(k) Number |
K880196 |
Device Name |
LAMINARIA |
Applicant |
MEDGYN PRODUCTS, INC. |
2808 A. CENTER CIRCLE |
DOWNERS GROVE,
IL
60515
|
|
Applicant Contact |
LAKSHMAN AGADI |
Correspondent |
MEDGYN PRODUCTS, INC. |
2808 A. CENTER CIRCLE |
DOWNERS GROVE,
IL
60515
|
|
Correspondent Contact |
LAKSHMAN AGADI |
Regulation Number | 884.4260
|
Classification Product Code |
|
Date Received | 01/26/1988 |
Decision Date | 05/06/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|