Device Classification Name |
Condom
|
510(k) Number |
K202403 |
Device Name |
SKORE (Colors & Flavors), SKORE (Colors) |
Applicant |
TTK Healthcare Limited |
12, K P Natham Road, Thiruvandar Koil, |
Puducherry,
IN
605102
|
|
Applicant Contact |
Daniel J. S. |
Correspondent |
TTK Healthcare Limited |
6, Cathedral Road |
Chennai,
IN
600086
|
|
Correspondent Contact |
Daniel J. S. |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 08/21/2020 |
Decision Date | 04/15/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|