Device Classification Name |
cannula, intrauterine insemination
|
510(k) Number |
K914541 |
Device Name |
SPERM MAINTENANCE MEDIUM WITH GLYCEROL |
Applicant |
IRVINE SCIENTIFIC |
2511 DAIMLER ST. |
SANTA ANA,
CA
92705
|
|
Applicant Contact |
PAUL S WEATHERSBEE |
Correspondent |
IRVINE SCIENTIFIC |
2511 DAIMLER ST. |
SANTA ANA,
CA
92705
|
|
Correspondent Contact |
PAUL S WEATHERSBEE |
Regulation Number | 884.5250
|
Classification Product Code |
|
Date Received | 10/11/1991 |
Decision Date | 02/03/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|