Device Classification Name |
Brush, Endometrial
|
510(k) Number |
K082066 |
Device Name |
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER |
Applicant |
COOK UROLOGICAL, INC. |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Applicant Contact |
CINDY FOOTE |
Correspondent |
COOK UROLOGICAL, INC. |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Correspondent Contact |
CINDY FOOTE |
Regulation Number | 884.1100
|
Classification Product Code |
|
Date Received | 07/22/2008 |
Decision Date | 11/07/2008 |
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
|
|
|