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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 K971236
Device Name GREINER VACUETTE BLOOD COLLECTION TUBE
Applicant
GREINER AMERICA, INC.
P.O. BOX 953279
LAKE MARY,  FL  32795 -3279
Applicant Contact ED MAIER
Correspondent
GREINER AMERICA, INC.
P.O. BOX 953279
LAKE MARY,  FL  32795 -3279
Correspondent Contact ED MAIER
Regulation Number862.1675
Classification Product Code
JKA  
Date Received04/02/1997
Decision Date 05/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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