Device Classification Name |
condom
|
510(k) Number |
K820564 |
Device Name |
WORLD'S BEST (CONTRACEPTIVE) |
Applicant |
ROSEN KILDE STENHOJ |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
ROSEN KILDE STENHOJ |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 03/02/1982 |
Decision Date | 05/28/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|