Device Classification Name |
Colposcope (And Colpomicroscope)
|
510(k) Number |
K090324 |
Device Name |
ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY |
Applicant |
STI MEDICAL SYSTEMS |
733 BISHOP STREET |
SUITE 3100 |
HONOLULU,
HI
96813
|
|
Applicant Contact |
ROLF WOLTERS |
Correspondent |
STI MEDICAL SYSTEMS |
733 BISHOP STREET |
SUITE 3100 |
HONOLULU,
HI
96813
|
|
Correspondent Contact |
ROLF WOLTERS |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 02/09/2009 |
Decision Date | 12/20/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|