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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K090581
Device Name TANTALUM BEAD SET, MODEL P003175
Applicant
Halifax Biomedical, Inc.
4 Innovation Dr.
Dundas,  CA L9H 7P3
Applicant Contact ROSHANA AHMED
Correspondent
Halifax Biomedical, Inc.
4 Innovation Dr.
Dundas,  CA L9H 7P3
Correspondent Contact ROSHANA AHMED
Regulation Number878.4300
Classification Product Code
NEU  
Date Received03/03/2009
Decision Date 08/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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