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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K983952
Device Name GREINER VACUETTE BLOOD COLLECTION TUBE
Applicant
Greiner Meditech, Inc.
260 Gateway Dr., Suite 17a
Bel Air,  MD  21014
Applicant Contact DOUG HARRIS
Correspondent
Greiner Meditech, Inc.
260 Gateway Dr., Suite 17a
Bel Air,  MD  21014
Correspondent Contact DOUG HARRIS
Regulation Number862.1675
Classification Product Code
JKA  
Date Received11/05/1998
Decision Date 12/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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