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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
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 Number884.5300
Classification Product Code
HIS  
Date Received07/25/2012
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
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