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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Wound Dressing Without Thrombin Or Other Biologics
510(k) Number K113560
Device Name CELOX GAUZE PRO
Applicant
Medtrade Products , Ltd.
Electra House
Crewe Business Park Crewe
Cheshire,  GB CW1 6GL
Applicant Contact CLAIRE RYAN
Correspondent
Medtrade Products , Ltd.
Electra House
Crewe Business Park Crewe
Cheshire,  GB CW1 6GL
Correspondent Contact CLAIRE RYAN
Classification Product Code
QSY  
Date Received12/01/2011
Decision Date 08/01/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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