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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 K061079
Device Name MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
Applicant
Medtrade Products , Ltd.
Electra House, Crewe Business Park
Crewe,  GB CW1 6GL
Applicant Contact JONATHAN D RANFIELD
Correspondent
Medtrade Products , Ltd.
Electra House, Crewe Business Park
Crewe,  GB CW1 6GL
Correspondent Contact JONATHAN D RANFIELD
Classification Product Code
QSY  
Date Received04/17/2006
Decision Date 06/02/2006
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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