VIELLE LUBRICANT

Condom

CST MEDICAL LIMITED

The following data is part of a premarket notification filed by Cst Medical Limited with the FDA for Vielle Lubricant.

Pre-market Notification Details

Device IDK051288
510k NumberK051288
Device Name:VIELLE LUBRICANT
ClassificationCondom
Applicant CST MEDICAL LIMITED 1676 VILLAGE GREEN SUITE A Crofton,  MD  21114
ContactChristian Smith
CorrespondentChristian Smith
CST MEDICAL LIMITED 1676 VILLAGE GREEN SUITE A Crofton,  MD  21114
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-18
Decision Date2006-02-03
Summary:summary

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