Device Classification Name |
Colposcope (And Colpomicroscope)
|
510(k) Number |
K021153 |
Device Name |
GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000 |
Applicant |
GOLDWAY US, INC. |
12 SOUTH FIRST STREET, |
SUITE 1205 |
SAN JOSE,
CA
95113
|
|
Applicant Contact |
Y. JUSTIN CHEN |
Correspondent |
GOLDWAY US, INC. |
12 SOUTH FIRST STREET, |
SUITE 1205 |
SAN JOSE,
CA
95113
|
|
Correspondent Contact |
Y. JUSTIN CHEN |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 04/10/2002 |
Decision Date | 02/10/2003 |
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
|
|
|