Device Classification Name |
Condom
|
510(k) Number |
K990597 |
Device Name |
SUMMER'S EVE LUBRICATING JELLY |
Applicant |
C.B. FLEET CO., INC. |
1050 CONNECTICUT AVENUE N.W. |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
PETER S REICHERTZ |
Correspondent |
C.B. FLEET CO., INC. |
1050 CONNECTICUT AVENUE N.W. |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
PETER S REICHERTZ |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/24/1999 |
Decision Date | 07/19/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|