NON ADHERENT BANDAGE/SHEET

Dressing, Wound, Drug

AMERICAN MEDICAL DISPOSABLE, INC.

The following data is part of a premarket notification filed by American Medical Disposable, Inc. with the FDA for Non Adherent Bandage/sheet.

Pre-market Notification Details

Device IDK833730
510k NumberK833730
Device Name:NON ADHERENT BANDAGE/SHEET
ClassificationDressing, Wound, Drug
Applicant AMERICAN MEDICAL DISPOSABLE, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-10-25
Decision Date1984-01-27

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