Device Classification Name |
Media, Reproductive
|
510(k) Number |
K983580 |
Device Name |
BLASTOCYST MEDIUM |
Applicant |
IRVINE SCIENTIFIC SALES CO., INC. |
2511 DAIMLER ST. |
SANTA ANA,
CA
92705
|
|
Applicant Contact |
ROBERTA L JOHNSON |
Correspondent |
IRVINE SCIENTIFIC SALES CO., INC. |
2511 DAIMLER ST. |
SANTA ANA,
CA
92705
|
|
Correspondent Contact |
ROBERTA L JOHNSON |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 10/13/1998 |
Decision Date | 02/18/1999 |
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
|
|
|