Device Classification Name |
condom
|
510(k) Number |
K210208 |
Device Name |
Titan Condoms |
Applicant |
Titan Condoms LLC |
1950 Elkhorn Ct. Unit. 210 |
San Mateo,
CA
94403
|
|
Applicant Contact |
Neville Muringayi |
Correspondent |
Medicsense USA |
291 Hillside Avenue |
Somerset,
MA
02726
|
|
Correspondent Contact |
George Hattub |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 01/26/2021 |
Decision Date | 02/17/2022 |
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
|
|
|