510(k) K070965

ALICIA MENSTRUAL CUP by Alicia International Pty , Ltd. — Product Code HHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2008
Date Received
April 5, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cup, Menstrual
Device Class
Class II
Regulation Number
884.5400
Review Panel
OB
Submission Type

A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.