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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 K033291
Device Name TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
Applicant
Radi Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE S-754 50
Applicant Contact HELENE EKSTRAND
Correspondent
Radi Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE S-754 50
Correspondent Contact HELENE EKSTRAND
Classification Product Code
QSY  
Date Received10/14/2003
Decision Date 03/17/2004
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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