Device Classification Name |
condom
|
510(k) Number |
K905854 |
Device Name |
CONDOMS |
Applicant |
BARNETTS, INC. |
3630 TRYCLAN DR. |
CHARLOTTE,
NC
28217
|
|
Applicant Contact |
J. M BARNETT |
Correspondent |
BARNETTS, INC. |
3630 TRYCLAN DR. |
CHARLOTTE,
NC
28217
|
|
Correspondent Contact |
J. M BARNETT |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/18/1990 |
Decision Date | 02/15/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|