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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, biopsy, mechanical, gastrointestinal
510(k) Number K062833
Device Name POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM
Applicant
VIDACARE CORPORATION
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
VIDACARE CORPORATION
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number876.1075
Classification Product Code
FCF  
Subsequent Product Code
GDM  
Date Received09/21/2006
Decision Date 11/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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