Device Classification Name |
Condom
|
510(k) Number |
K010028 |
Device Name |
SHEER THIN AROMAS RED LATEX CONDOM |
Applicant |
EAGLE TWE, INC. |
2090 TUCKER INDUSTRIAL RD. |
TUCKER,
GA
30084
|
|
Applicant Contact |
KEITH HEINTZ |
Correspondent |
EAGLE TWE, INC. |
2090 TUCKER INDUSTRIAL RD. |
TUCKER,
GA
30084
|
|
Correspondent Contact |
KEITH HEINTZ |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 01/03/2001 |
Decision Date | 03/30/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|