Device Classification Name |
condom
|
510(k) Number |
K872504 |
Device Name |
LUBRICATED CONDOM |
Applicant |
ROYAL AMERICAN INDUSTRIES, INC. |
10309 SILVER LAKE DR. |
BOCA RATON,
FL
33428
|
|
Applicant Contact |
IRWIN VOLIN |
Correspondent |
ROYAL AMERICAN INDUSTRIES, INC. |
10309 SILVER LAKE DR. |
BOCA RATON,
FL
33428
|
|
Correspondent Contact |
IRWIN VOLIN |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 06/24/1987 |
Decision Date | 11/20/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|