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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 K091754
Device Name LUNETTE MENSTRUAL CUP, MODELS 1 AND 2
Applicant
LUNE GROUP LTD.
1920 ARLINGTON PLACE
madison,  WI  53726
Applicant Contact morris waxler
Correspondent
LUNE GROUP LTD.
1920 ARLINGTON PLACE
madison,  WI  53726
Correspondent Contact morris waxler
Regulation Number884.5400
Classification Product Code
HHE  
Date Received06/16/2009
Decision Date 11/13/2009
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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