Device Classification Name |
Spatula, Cervical, Cytological
|
510(k) Number |
K013258 |
Device Name |
INPATH E2 COLLECTOR |
Applicant |
MOLECULAR DIAGNOSTICS |
414 N. ORLEANS |
SUITE 510 |
CHICAGO,
IL
60610
|
|
Applicant Contact |
ROBERT L HABIG |
Correspondent |
MOLECULAR DIAGNOSTICS |
414 N. ORLEANS |
SUITE 510 |
CHICAGO,
IL
60610
|
|
Correspondent Contact |
ROBERT L HABIG |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 10/01/2001 |
Decision Date | 05/31/2002 |
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
|
|
|