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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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ana 70 non gamma 2 dispersed phase dental alloy NORDISKA DENTAL AB k002811 10/31/2000
retinadx REGULATORY ASSOCIATES, INC. k003236 11/02/2000
mercury medical hyperinflation bag system, model 83-900-0149 MERCURY MEDICAL k001714 11/03/2000
modification to hermes operating room control center COMPUTER MOTION, INC. k003222 11/03/2000
rs nitrilstst medical examination gloves, powdered (non sterile) blue RIVERSTONE RESOURCES SDN. BHD. k003233 11/03/2000
friendly light er:yag pulsed laser INNOTECH USA, INC. k000023 11/06/2000
pe.r.i. ii knee fracture system DEPUY ORTHOPAEDICS, INC. k003235 11/06/2000
wec-7101a pocket size ecg monitor and accessories NIHON KOHDEN AMERICA, INC. k002473 11/08/2000
brentwood iqmark digital spirometer (includes disposable pneumotach mouthpieces and 3-liter calibration syringe BRENTWOOD MEDICAL TECHNOLOGY CORP. k002499 11/08/2000
ceram-prime S & C POLYMER GMBH k002502 11/08/2000

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