Atteris Antimicrobial Skin Protectant

Dressing, Wound, Drug

ROCHAL INDUSTRIES LLC

The following data is part of a premarket notification filed by Rochal Industries Llc with the FDA for Atteris Antimicrobial Skin Protectant.

Pre-market Notification Details

Device IDK161212
510k NumberK161212
Device Name:Atteris Antimicrobial Skin Protectant
ClassificationDressing, Wound, Drug
Applicant ROCHAL INDUSTRIES LLC 12719 CRANES MILL San Antonio,  TX  78230
ContactWilliam J. Coulston
CorrespondentWilliam J. Coulston
ROCHAL INDUSTRIES LLC 12719 CRANES MILL San Antonio,  TX  78230
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2016-04-28
Decision Date2016-09-30
Summary:summary

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