Device Classification Name |
Condom
|
510(k) Number |
K051273 |
Device Name |
DIVAS DUAL PLEASURE MALE LATEX CONDOM |
Applicant |
EAGLE TWE, INC. |
2090 TUCKER INDUSTRIAL ROAD |
SUITE A-5 |
TUCKER,
GA
30084
|
|
Applicant Contact |
BILL TAFFS |
Correspondent |
EAGLE TWE, INC. |
2090 TUCKER INDUSTRIAL ROAD |
SUITE A-5 |
TUCKER,
GA
30084
|
|
Correspondent Contact |
BILL TAFFS |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 05/17/2005 |
Decision Date | 08/19/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|