Device Classification Name |
Condom
|
510(k) Number |
K884925 |
Device Name |
THE GREAT WALL CONDOM |
Applicant |
PACIFIC SALES & DEVELOPMENT CORP. |
811 WEST NAPA ST. |
SONOMA,
CA
95476
|
|
Applicant Contact |
DARIO BENEDETTI |
Correspondent |
PACIFIC SALES & DEVELOPMENT CORP. |
811 WEST NAPA ST. |
SONOMA,
CA
95476
|
|
Correspondent Contact |
DARIO BENEDETTI |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 11/28/1988 |
Decision Date | 06/23/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|