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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 K120107
Device Name SCKOONCUP
Applicant
SCKOON INC.
2301 COLLINS AVE
#310
MIAMI BEACH,  FL  33139
Applicant Contact MOHAMED ELGAYAR
Correspondent
SCKOON INC.
2301 COLLINS AVE
#310
MIAMI BEACH,  FL  33139
Correspondent Contact MOHAMED ELGAYAR
Regulation Number884.5400
Classification Product Code
HHE  
Date Received01/13/2012
Decision Date 09/18/2012
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
Predetermined Change
Control Plan Authorized		 No
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