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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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perry-kolberg (pk) ha-coated titanium sleeve INTEGRATED ORBITAL IMPLANTS, INC. k000151 04/10/2000
kippmed i.v. manifold THE KIPP GROUP k000152 02/29/2000
arthro-surgimat-a103 W.O.M. WORLD OF MEDICINE, GMBH k000153 02/08/2000
eliachar laryngeal foam stent, model ell-1 E. BENSON HOOD LAB, INC. k000154 03/29/2000
elecsys anti-thyroid peroxidase antibody test system ROCHE DIAGNOSTICS CORP. k000155 05/17/2000
smart shield non-sterile powder-free peppermint scented green latex examination gloves SHIELD GLOVES MANUFACTURER (M) SDN BHD k000156 02/18/2000
veinlase, model e50-k8-b5, spectrum k8, model e50-k8-b9 FISMA, INC. k000158 08/24/2000
agfa diagnostic center adc, adc compact, and adc solo AGFA CORP. k000159 02/16/2000
metriscan bone density system ALARA, INC. k000162 05/12/2000
royal shield non-sterile purple (pink/blue) colored powdered latex exam with protein labeling claim [<200 mcg or less] w SHIELD GLOVES MANUFACTURER (M) SDN BHD k000217 02/18/2000

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