Device Classification Name |
Condom
|
510(k) Number |
K871358 |
Device Name |
SENSATIONS BRAND CONDOMS |
Applicant |
APEX MEDICAL TECHNOLOGIES, INC. |
10064 MESA RIDGE CT., #202 |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
ALICE A DEPAUL |
Correspondent |
APEX MEDICAL TECHNOLOGIES, INC. |
10064 MESA RIDGE CT., #202 |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
ALICE A DEPAUL |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 04/06/1987 |
Decision Date | 03/01/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|