Device Classification Name |
Condom
|
510(k) Number |
K122219 |
Device Name |
THEYFIT MALE CONDOM |
Applicant |
THEYFIT |
717 LAKEGLEN DRIVE |
SUWANEE,
GA
30024
|
|
Applicant Contact |
PENNY NORTHCUTT |
Correspondent |
THEYFIT |
717 LAKEGLEN DRIVE |
SUWANEE,
GA
30024
|
|
Correspondent Contact |
PENNY NORTHCUTT |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 07/25/2012 |
Decision Date | 09/27/2013 |
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
|
|
|