Device Classification Name |
Microtools, Assisted Reproduction (Pipettes)
|
510(k) Number |
K033904 |
Device Name |
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) |
Applicant |
COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. |
SPENCER,
IN
47460
|
|
Applicant Contact |
BRENDA DAVIS |
Correspondent |
COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. |
SPENCER,
IN
47460
|
|
Correspondent Contact |
BRENDA DAVIS |
Regulation Number | 884.6130
|
Classification Product Code |
|
Date Received | 12/17/2003 |
Decision Date | 01/16/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|