CHITOGAUZE

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 Chitogauze.

Pre-market Notification Details

Device IDK102546
510k NumberK102546
Device Name:CHITOGAUZE
ClassificationDressing, Wound, Drug
Applicant HEMCON MEDICAL TECHNOLOGIES, INC. 10575 SW CASCADE AVENUE SUITE 130 Portland,  OR  97223 -4363
ContactKendra Rathkey
CorrespondentKendra Rathkey
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-03
Decision Date2010-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50870053000136 K102546 000
50870053000013 K102546 000
50870053000310 K102546 000
20870053000562 K102546 000

Trademark Results [CHITOGAUZE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CHITOGAUZE
CHITOGAUZE
77611455 3825898 Live/Registered
TRICOL BIOMEDICAL, INC.
2008-11-10

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