FDA 510(k) Application Details - K120107

Device Classification Name	Cup, Menstrual   More FDA Info for this Device
510(K) Number	K120107
Device Name	Cup, Menstrual
Applicant	SCKOON INC. 2301 COLLINS AVE #310 MIAMI BEACH, FL 33139 US Other 510(k) Applications for this Company
Contact	MOHAMED ELGAYAR Other 510(k) Applications for this Contact
Regulation Number	884.5400   More FDA Info for this Regulation Number
Classification Product Code	HHE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/2012
Decision Date	09/18/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review