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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 K003812
Device Name VACUETTE SPEEDY QUICK-RELEASE HOLDER
Applicant
Greiner Vacuette North America, Inc.
P.O.Box 103
Baldwin,  MD  21013
Applicant Contact Judi Smith
Correspondent
Greiner Vacuette North America, Inc.
P.O.Box 103
Baldwin,  MD  21013
Correspondent Contact Judi Smith
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/11/2000
Decision Date 04/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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