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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
Date
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fiax complement c4 test kit INTL. DIAGNOSTIC TECHNOLOGY k830669 04/08/1983
titan gel ldh iso-enzyme control HELENA LABORATORIES k830872 04/12/1983
sysmex cc-130 TOA MEDICAL ELECTRONICS USA, INC. k830505 05/09/1983
chemonucleolysis table extension ORTHOPEDIC SYSTEMS, INC. k831042 05/16/1983
gentamicin calibrator -aca E.I. DUPONT DE NEMOURS & CO., INC. k831209 05/16/1983
model fm5 SONICAID, INC. k831371 06/30/1983
next step powder free latex examination gloves contains 50 mcgm or less of total water extractable protein per gram ANSELL PERRY k000165 03/10/2000
single size tendon spacer MEDIST INTERNATIONAL k000019 03/29/2000
vitaport 3 NIHON KOHDEN AMERICA, INC. k000338 04/26/2000
plain and chronic gut absorbable surgical sutures, usp ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. k000542 04/28/2000

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