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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K100665
Device Name MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX
Applicant
NEEDLETECH PRODUCTS, INC.
81 WEST ST.
ATTLEBORO,  MA  02703
Applicant Contact RICK TRIPP
Correspondent
NEEDLETECH PRODUCTS, INC.
81 WEST ST.
ATTLEBORO,  MA  02703
Correspondent Contact RICK TRIPP
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/08/2010
Decision Date 06/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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