2018 ARTERIAL/VENOUS PRESSURE DRESSING

Dressing, Wound, Drug

ADVANCE MEDICAL DESIGNS, INC.

The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for 2018 Arterial/venous Pressure Dressing.

Pre-market Notification Details

Device IDK895845
510k NumberK895845
Device Name:2018 ARTERIAL/VENOUS PRESSURE DRESSING
ClassificationDressing, Wound, Drug
Applicant ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta,  GA  30062
ContactRonald D Arkin
CorrespondentRonald D Arkin
ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta,  GA  30062
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-03
Decision Date1989-11-01

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