Device Classification Name |
Colposcope (And Colpomicroscope)
|
510(k) Number |
K070845 |
Device Name |
SOUNMED COLOPOSCOPE COLPO-99/99PLUS |
Applicant |
SOUNMED, INC. |
6800 N.W. 77TH COURT |
MIAMI,
FL
33166
|
|
Applicant Contact |
RUBEN OLIVARES |
Correspondent |
SOUNMED, INC. |
6800 N.W. 77TH COURT |
MIAMI,
FL
33166
|
|
Correspondent Contact |
RUBEN OLIVARES |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 03/27/2007 |
Decision Date | 10/12/2007 |
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
|
|
|