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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cup, menstrual
510(k) Number K140626
Device Name MELUNA CLASSIC/SPORT MENSTRUAL CUP
Applicant
MELUNA
1468 HARWELL AVE
crofton,  MD  21114
Applicant Contact yolanda smith
Correspondent
MELUNA
1468 HARWELL AVE
crofton,  MD  21114
Correspondent Contact yolanda smith
Regulation Number884.5400
Classification Product Code
HHE  
Date Received03/11/2014
Decision Date 07/10/2014
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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