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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
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hardy disk clarithromycin, 15mcg HARDY DIAGNOSTICS k001728 07/27/2000
focus INSTRUMENTARIUM CORP. k001729 07/13/2000
gc fujicem GC AMERICA, INC. k001730 07/17/2000
avid-nit loss of resistance syringe AVID MEDICAL, INC. k001731 08/29/2000
allen medullary cement plugs, zimmer poly plug intramedullary system, model 8011 series & 1109 & 8109 series ZIMMER, INC. k001733 06/20/2000
fogarty valvulotome, model 700091 EDWARDS LIFESCIENCES, LLC. k001734 03/26/2001
galeo hydro and galeo hydro j-tip BIOTRONIK, INC. k001736 08/02/2000
opaque herrick plug, 0.3mm; 0.5mm; o.7mm LACRIMEDICS, INC. k001737 06/19/2000
depuy restore orthobiologic soft tissue implant DEPUY ORTHOPAEDICS, INC. k001738 12/27/2000
polymer coated powder-free latex examination gloves, contains 50 micrograms or less of total water extractable protein p ALLEGIANCE HEALTHCARE CORP. k001739 07/27/2000

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