Device Classification Name |
Colposcope (And Colpomicroscope)
|
510(k) Number |
K902313 |
Device Name |
LM-1Z ZOOM SCOPE |
Applicant |
LEISEGANG MEDICAL, INC. |
6401 CONGRESS AVE. |
BOCA RATON,
FL
33487 -2883
|
|
Applicant Contact |
DOUGLAS KWART |
Correspondent |
LEISEGANG MEDICAL, INC. |
6401 CONGRESS AVE. |
BOCA RATON,
FL
33487 -2883
|
|
Correspondent Contact |
DOUGLAS KWART |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 05/23/1990 |
Decision Date | 09/04/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|