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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dressing, wound, drug
510(k) Number K121485
Device Name GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
Original Applicant
HEMCON MEDICAL TECHNOLOGIES EUROPE LTD
10575 sw cascade avenue
suite 130
portland,  OR  97223 4363
Original Contact barbara mcgrath
Classification Product Code
FRO  
Date Received05/18/2012
Decision Date 08/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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