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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
510(k) Number K120002
Device Name I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
Original Applicant
BUSSE HOSPITAL DISPOSABLES, INC.
75 arkay dr.
hauppauge,  NY  11788
Original Contact muhamad ansari
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/09/2012
Decision Date 06/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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