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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name condom
510(k) Number K122219
Device Name THEYFIT MALE CONDOM
Original Applicant
THEYFIT
717 lakeglen drive
suwanee,  GA  30024
Original Contact penny northcutt
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/25/2012
Decision Date 09/27/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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