Device Classification Name |
Condom
|
510(k) Number |
K880189 |
Device Name |
NEW JELLIACOAT |
Applicant |
K&G IMPORT/EXPORT CO. |
6417 WESTERN AVE. |
WHITTIER,
CA
90606
|
|
Applicant Contact |
GERARD GONZALES |
Correspondent |
K&G IMPORT/EXPORT CO. |
6417 WESTERN AVE. |
WHITTIER,
CA
90606
|
|
Correspondent Contact |
GERARD GONZALES |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 01/20/1988 |
Decision Date | 06/27/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|