Device Classification Name |
Spatula, Cervical, Cytological
|
510(k) Number |
K062433 |
Device Name |
DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM |
Applicant |
DIAMICS, INC. |
SIX HAMILTON LANDING SUITE 200 |
NOVATO,
CA
94949
|
|
Applicant Contact |
PETER GOMBRICH |
Correspondent |
DIAMICS, INC. |
SIX HAMILTON LANDING SUITE 200 |
NOVATO,
CA
94949
|
|
Correspondent Contact |
PETER GOMBRICH |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 08/21/2006 |
Decision Date | 03/16/2007 |
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
|
|
|