MEPILEX AG DRESSING

Dressing, Wound, Drug

MONLYCKE HEALTH CARE

The following data is part of a premarket notification filed by Monlycke Health Care with the FDA for Mepilex Ag Dressing.

Pre-market Notification Details

Device IDK071354
510k NumberK071354
Device Name:MEPILEX AG DRESSING
ClassificationDressing, Wound, Drug
Applicant MONLYCKE HEALTH CARE 5550 PEACHTREE PKWY. SUITE 500 Norcross,  GA  30092
ContactSteven Dowdley
CorrespondentSteven Dowdley
MONLYCKE HEALTH CARE 5550 PEACHTREE PKWY. SUITE 500 Norcross,  GA  30092
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2007-05-15
Decision Date2007-07-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332551971779 K071354 000
07332551226954 K071354 000
07332430612151 K071354 000
07323190132966 K071354 000
07332430612076 K071354 000
07332430612038 K071354 000

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