| Device Classification Name |
System, Water, Reproduction, Assisted, And Purification
|
| 510(k) Number |
K993140 |
| Device Name |
WATER FOR TISSUE CULTURE, MODELS 1500 |
| Applicant |
| Conception Technologies |
| 3722 Ave. Sausalito |
|
Irvine,
CA
92606
|
|
| Applicant Contact |
GREG HOLLAND |
| Correspondent |
| Conception Technologies |
| 3722 Ave. Sausalito |
|
Irvine,
CA
92606
|
|
| Correspondent Contact |
GREG HOLLAND |
| Regulation Number | 884.6170 |
| Classification Product Code |
|
| Date Received | 09/20/1999 |
| Decision Date | 08/02/2000 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|