RHEA CUP

Cup, Menstrual

APEX MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Apex Medical Technologies, Inc. with the FDA for Rhea Cup.

Pre-market Notification Details

Device IDK112165
510k NumberK112165
Device Name:RHEA CUP
ClassificationCup, Menstrual
Applicant APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego,  CA  92121
ContactScott Herrick
CorrespondentScott Herrick
APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego,  CA  92121
Product CodeHHE  
CFR Regulation Number884.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-28
Decision Date2012-05-24
Summary:summary

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