Device Classification Name |
speculum, vaginal, nonmetal, fiberoptic
|
510(k) Number |
K923656 |
Device Name |
LIGHTING SOURCE SYSTEM |
Applicant |
GALENICA ENTERPRISES, INC. |
C.P. 13 |
STE-THERESE |
QUEBEC CANADA J7E 4H7,
CA
|
|
Applicant Contact |
BETTY MAILOT |
Correspondent |
GALENICA ENTERPRISES, INC. |
C.P. 13 |
STE-THERESE |
QUEBEC CANADA J7E 4H7,
CA
|
|
Correspondent Contact |
BETTY MAILOT |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 07/13/1992 |
Decision Date | 09/08/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|