Device Classification Name |
System, Water, Reproduction, Assisted, And Purification
|
510(k) Number |
K011598 |
Device Name |
WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE |
Applicant |
IRVINE SCIENTIFIC SALES CO., INC. |
2511 DAIMLER ST. |
SANTA ANA,
CA
92705
|
|
Applicant Contact |
WENDELL LEE |
Correspondent |
IRVINE SCIENTIFIC SALES CO., INC. |
2511 DAIMLER ST. |
SANTA ANA,
CA
92705
|
|
Correspondent Contact |
WENDELL LEE |
Regulation Number | 884.6170
|
Classification Product Code |
|
Date Received | 05/24/2001 |
Decision Date | 06/13/2001 |
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
|
|
|