MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC

Dressing, Wound, Drug

HEMCON MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Hemcon Medical Technologies, Inc. with the FDA for Modification To Hemcon Bandage And Hemcon Bandage Otc.

Pre-market Notification Details

Device IDK072486
510k NumberK072486
Device Name:MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC
ClassificationDressing, Wound, Drug
Applicant HEMCON MEDICAL TECHNOLOGIES, INC. 10575 SW CASCADE AVENUE SUITE 130 Portland,  OR  97223 -4363
ContactKevin Hawkins
CorrespondentKevin Hawkins
HEMCON MEDICAL TECHNOLOGIES, INC. 10575 SW CASCADE AVENUE SUITE 130 Portland,  OR  97223 -4363
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2007-09-04
Decision Date2008-08-06
Summary:summary

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