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510(k) K091754

LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 by Lune Group , Ltd. — Product Code HHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2009
Date Received
June 16, 2009
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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  • K092985 — BELLECUP (June 28, 2010)
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  • K060852 — MOONCUP (December 26, 2006)
  • K040335 — MOONCUP, STYLE A & B (March 30, 2005)
  • K021356 — THE DIVACUP MENSTRUAL SOLUTION (July 16, 2002)