THEYFIT MALE CONDOM


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

Correspodent Contact penny northcutt
Regulation Number 884.5300
Classification Product Code
HIS  
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