Device Classification Name |
cap, cervical
|
510(k) Number |
K872203 |
Device Name |
CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) |
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 | 06/08/1987 |
Decision Date | 08/14/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|