Device Classification Name |
Colposcope (And Colpomicroscope)
|
510(k) Number |
K000707 |
Device Name |
LEICA COLPOSCOPE |
Applicant |
LEICA MICROSCOPY SYSTEMS LTD. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
LEICA MICROSCOPY SYSTEMS LTD. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 03/02/2000 |
Decision Date | 06/27/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|