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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K113505
Device Name VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER
Applicant
Greiner Bio-One North America, Inc.
P.O.Box 103
Baldwin,  MD  21013
Applicant Contact Judi Smith
Correspondent
Greiner Bio-One North America, Inc.
P.O.Box 103
Baldwin,  MD  21013
Correspondent Contact Judi Smith
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/28/2011
Decision Date 02/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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