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510(k) K021356

THE DIVACUP MENSTRUAL SOLUTION by Diva International, Inc. — Product Code HHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2002
Date Received
April 29, 2002
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.

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