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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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atac pak alp reagent kit ELAN DIAGNOSTICS k002285 09/26/2000
breathing filter for disposable anesthesia breathing circuit SIMS PORTEX, INC. k002506 12/14/2000
protein c reagent DADE BEHRING, INC. k002541 09/26/2000
modification to profile -ii MEDTOX DIAGNOSTICS, INC. k002776 09/28/2000
copeland resurfacing heads BIOMET, INC. k003044 12/13/2000
pump tubing with x-coating TERUMO CORP. k003371 12/21/2000
leibinger neuro clip system STRYKER INSTRUMENTS k003660 12/12/2000
afx microwave generator, flex ablation wand, lynx ablation wand, model series 1000, p/n 102006, p/n 102007 AFX, INC. k003978 05/22/2001
av 800 ventilator PENLON LTD. k010317 07/23/2001
at home drug test, model 9068 t PHAMATECH k010653 04/05/2001

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