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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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510(K)
Number
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Decision
Date
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calex conditioner STEPHEN M. KORAL, D.M.D. k010176 03/27/2001
capella MADSEN ELECTRONICS, INC. k002200 08/25/2000
cardiosentry event monitor, model 8470-01 TZ MEDICAL, INC. k001634 12/21/2000
caris site marker ARTEMIS MEDICAL, INC. k003777 03/06/2001
carony BRUNO INDEPENDENT LIVING AIDS, INC. k002205 08/10/2000
carriazo barraquer ii microkeratome MORIA, INC. k002191 10/12/2000
cartouch CARDIONICS, INC. k002197 12/27/2000
cbw bridge system (consisting of cbw andchors, cbw micro-handpiece and burs) CBS INTL. B.V. k002693 11/09/2000
cbyon surgical operating system (sos) CBYON, INC. k000171 03/13/2000
cd horizon spinal system, 4.5 rod for posterior application MEDTRONIC SOFAMOR DANEK, INC. k010181 06/12/2001

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