Device Classification Name |
cap, cervical
|
510(k) Number |
K871577 |
Device Name |
HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES |
Applicant |
IRVINE SCIENTIFIC |
2511 DAIMLER ST. |
SANTA ANA,
CA
92705
|
|
Applicant Contact |
PAUL WEATHERSBEE,PHD |
Correspondent |
IRVINE SCIENTIFIC |
2511 DAIMLER ST. |
SANTA ANA,
CA
92705
|
|
Correspondent Contact |
PAUL WEATHERSBEE,PHD |
Regulation Number | 884.5250
|
Classification Product Code |
|
Date Received | 04/23/1987 |
Decision Date | 07/15/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|