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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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smith & nephew porps & torps GYRUS ENT L.L.C. k002737 10/12/2000
bayer rapidpoint 400 system BAYER CORP. k002738 12/19/2000
licox cmp monitor-ac3.1, licox imc oxygen catheters-cc1,cc1.sb luicox imc introducer kits-im,im2,im3,ii1 licoximc tempe INTEGRA NEUROSCIENCES k002765 11/24/2000
harald nordin glassix glass fiber composite dental post HARALD NORDIN S.A k003221 10/25/2000
modification to hermes operating room control center COMPUTER MOTION, INC. k003222 11/03/2000
geon digital clinical thermometer GEON CORP. k003223 01/12/2001
solution administration sets with capless luer activated valve BAXTER HEALTHCARE CORP. k003225 10/19/2000
the lifecore stage-1 single stage rbm dental implant system LIFECORE BIOMEDICAL, INC. k003226 01/12/2001
bio-absorbable corkscrew model ar-1920b ARTHREX, INC. k003227 01/08/2001
k-defib/pace multifuction pediatric electrode, model kdp-70a KATECHO, INC. k003228 12/14/2000

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