INTEGRA Wound Matrix (Macro-Channels)

Dressing, Wound, Collagen

Integra LifeSciences Corporation

The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Wound Matrix (macro-channels).

Pre-market Notification Details

Device IDK210128
510k NumberK210128
Device Name:INTEGRA Wound Matrix (Macro-Channels)
ClassificationDressing, Wound, Collagen
Applicant Integra LifeSciences Corporation 1100 Campus Road Princeton,  NJ  08540
ContactSaakshi Arora-tice
CorrespondentNicole Kotter
Integra LifeSciences Corporation 1100 Campus Road Princeton,  NJ  08540
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-19
Decision Date2021-10-08

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