MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG

Dressing, Wound, Drug

MEDIPURPOSE PTE. LTD.

The following data is part of a premarket notification filed by Medipurpose Pte. Ltd. with the FDA for Mediplus-foam Ag; Mediplus-comfortfoam Ag; Mediplus-superfoam Ag.

Pre-market Notification Details

Device IDK110062
510k NumberK110062
Device Name:MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG
ClassificationDressing, Wound, Drug
Applicant MEDIPURPOSE PTE. LTD. 111 LAUREL RIDGE DRIVE Alpharetta,  GA  30004
ContactJulie Stephens
CorrespondentJulie Stephens
MEDIPURPOSE PTE. LTD. 111 LAUREL RIDGE DRIVE Alpharetta,  GA  30004
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2011-01-10
Decision Date2011-09-01
Summary:summary

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