FDA 510(k) Applications for Medical Device Product Code "HHE"
(Cup, Menstrual)

FDA 510(k) Number Applicant Device Name Decision Date
K070965 ALICIA INTERNATIONAL PTY LTD. ALICIA MENSTRUAL CUP 03/05/2008
K112165 APEX MEDICAL TECHNOLOGIES, INC. RHEA CUP 05/24/2012
K021356 DIVA INTERNATIONAL INC THE DIVACUP MENSTRUAL SOLUTION 07/16/2002
K121857 FEMCAP INCORPORATED FEMMYCYCLE 11/15/2012
K092985 LIBRETTE, INC BELLECUP 06/28/2010
K091754 LUNE GROUP LTD. LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 11/13/2009
K140626 MELUNA MELUNA CLASSIC/SPORT MENSTRUAL CUP 07/10/2014
K060852 MOONCUP LIMITED MOONCUP 12/26/2006
K040335 MOONCUP LLC MOONCUP, STYLE A & B 03/30/2005
K120107 SCKOON INC. SCKOONCUP 09/18/2012
K971303 ULTRAFEM, INC. INSTEAD, SOFTCUP 06/06/1997


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