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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
Applicant
BUSSE HOSPITAL DISPOSABLES, INC.
75 arkay dr.
hauppauge,  NY  11788
Applicant Contact muhamad ansari
Correspondent
BUSSE HOSPITAL DISPOSABLES, INC.
75 arkay dr.
hauppauge,  NY  11788
Correspondent Contact muhamad ansari
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/03/2012
Decision Date 06/26/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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