Device Classification Name |
Condom
|
510(k) Number |
K980019 |
Device Name |
HTL MALE CONDOM |
Applicant |
REDDY MEDTECH HEALTH PRODUCTS LTD. |
S-59, 20TH ST. |
ANNANAGAR WEST |
CHENNAI,
IN
600 040
|
|
Applicant Contact |
A.V.K. REDDY |
Correspondent |
REDDY MEDTECH HEALTH PRODUCTS LTD. |
S-59, 20TH ST. |
ANNANAGAR WEST |
CHENNAI,
IN
600 040
|
|
Correspondent Contact |
A.V.K. REDDY |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 01/02/1998 |
Decision Date | 04/01/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|