Device Classification Name |
condom
|
510(k) Number |
K946207 |
Device Name |
CONQUEROR, RUMBA AND TEMPTATION |
Applicant |
FRONTLINE LATEX PRODUCTS PVT. LTD. |
57 WEST 38TH ST. |
2ND FLOOR |
NEW YORK,
NY
10018 -5500
|
|
Applicant Contact |
ASHEEM AGGARWAL |
Correspondent |
FRONTLINE LATEX PRODUCTS PVT. LTD. |
57 WEST 38TH ST. |
2ND FLOOR |
NEW YORK,
NY
10018 -5500
|
|
Correspondent Contact |
ASHEEM AGGARWAL |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/21/1994 |
Decision Date | 01/24/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|