Device Classification Name |
condom
|
510(k) Number |
K833365 |
Device Name |
ULTRA SHAPE CONDOMS |
Applicant |
BARNETTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
BARNETTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 09/27/1983 |
Decision Date | 08/22/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|