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510(k) K120107

SCKOONCUP by Sckoon, Inc. — Product Code HHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2012
Date Received
January 13, 2012
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.

Other clearances for product code HHE

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  • K140626 — MELUNA CLASSIC/SPORT MENSTRUAL CUP (July 10, 2014)
  • K121857 — FEMMYCYCLE (November 15, 2012)
  • K112165 — RHEA CUP (May 24, 2012)
  • K092985 — BELLECUP (June 28, 2010)
  • K091754 — LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 (November 13, 2009)
  • K070965 — ALICIA MENSTRUAL CUP (March 5, 2008)
  • K060852 — MOONCUP (December 26, 2006)
  • K040335 — MOONCUP, STYLE A & B (March 30, 2005)
  • K021356 — THE DIVACUP MENSTRUAL SOLUTION (July 16, 2002)