Device Classification Name |
Condom
|
510(k) Number |
K000040 |
Device Name |
INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED |
Applicant |
INDUS MEDICARE LTD. |
144, S.P. RD., BEGUMPET |
HYDERABAD ANDHRA PRADESH,
IN
500 016
|
|
Applicant Contact |
P.K. REDDY |
Correspondent |
INDUS MEDICARE LTD. |
144, S.P. RD., BEGUMPET |
HYDERABAD ANDHRA PRADESH,
IN
500 016
|
|
Correspondent Contact |
P.K. REDDY |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 01/06/2000 |
Decision Date | 03/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|