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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 K110883
Device Name J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA
Applicant
BUSSE HOSPITAL DISPOSABLES
75 ARKAY DRIVE
HAUPPAUGE,  NY  11788
Applicant Contact MUHAMAD ANSARI
Correspondent
BUSSE HOSPITAL DISPOSABLES
75 ARKAY DRIVE
HAUPPAUGE,  NY  11788
Correspondent Contact MUHAMAD ANSARI
Regulation Number876.1075
Classification Product Code
KNW  
Date Received03/30/2011
Decision Date 06/08/2011
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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