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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 K230589
Device Name Celox Rapid X-Ray Gauze
Applicant
Medtrade Products , Ltd.
Electra House, Crewe Business Park
Crewe,  GB CW1 6GL
Applicant Contact Kelsey Gomes
Correspondent
Medtrade Products , Ltd.
Electra House, Crewe Business Park
Crewe,  GB CW1 6GL
Correspondent Contact Mina Patel
Classification Product Code
QSY  
Date Received03/02/2023
Decision Date 11/17/2023
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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