KerraCel Ag Gelling Fiber Silver Dressing

Dressing, Wound, Drug

Exciton Technologies Inc.

The following data is part of a premarket notification filed by Exciton Technologies Inc. with the FDA for Kerracel Ag Gelling Fiber Silver Dressing.

Pre-market Notification Details

Device IDK162508
510k NumberK162508
Device Name:KerraCel Ag Gelling Fiber Silver Dressing
ClassificationDressing, Wound, Drug
Applicant Exciton Technologies Inc. 10230 Jasper Ave., Suite 4147 Edmonton,  CA T5j 4p6
ContactMelanie Ussyk
CorrespondentMelanie Ussyk
Exciton Technologies Inc. 10230 Jasper Ave., Suite 4147 Edmonton,  CA T5j 4p6
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2016-09-08
Decision Date2017-02-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060077233997 K162508 000
07540127000208 K162508 000
07540127000239 K162508 000
07540127000260 K162508 000
07540127000291 K162508 000
07540127000321 K162508 000
05060077233522 K162508 000
05060077233553 K162508 000
05060077233584 K162508 000
05060077233614 K162508 000
05060077233676 K162508 000
05060077233706 K162508 000
07540127000178 K162508 000

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