Device Classification Name |
microtools, assisted reproduction (pipettes)
|
510(k) Number |
K041562 |
Device Name |
CRYOTIP |
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 | 884.6130
|
Classification Product Code |
|
Date Received | 06/10/2004 |
Decision Date | 08/09/2004 |
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
|
|
|