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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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bayer rapidpoint 400 system BAYER CORP. k002738 12/19/2000
summit occipito-cervico-thoracic (oct) spinal system DEPUY ACROMED k002733 12/15/2000
bird tbird legacy ventilator BIRD PRODUCTS CORP. k003770 12/15/2000
k-defib/pace multifuction pediatric electrode, model kdp-70a KATECHO, INC. k003228 12/14/2000
creatinine JAS Diagnostics, Inc. k003247 12/14/2000
ecat pet scanner CTI PET SYSTEMS, INC. k003241 12/13/2000
pst electrosurgical generator, model 2150, pst bipolar forceps, model ebf 1228 PST, INC. k003249 12/12/2000
versabond bone cement SMITH & NEPHEW, INC. k001160 12/11/2000
hanger cranial band HANGER ORTHOPEDIC GROUP, INC. k001669 12/08/2000
com-med o.r. towel - non-sterile, blue, green, white COM-MED INTERNATIONAL, INC. k002691 12/08/2000

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