Device Classification Name |
Colposcope (And Colpomicroscope)
|
510(k) Number |
K791279 |
Device Name |
KOLPOSKOP KP20005 |
Applicant |
ELMED, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ELMED, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 07/10/1979 |
Decision Date | 09/17/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|