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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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evtool model # v. 1.0 3D LINE USA, INC. k013535 01/18/2002
exel injection plug with cap EXELINT INTL. CO. k011405 09/27/2001
extrude modified SYBRON DENTAL SPECIALTIES, INC. k012405 09/04/2001
fabius gs anesthesia system, model fabius gs DRAEGER MEDICAL, INC. k011404 02/22/2002
fadasis medical fm-1 no blender FADASIS MEDICAL, INC. k011874 07/20/2001
fas set #4551 GYNETICS MEDICAL PRODUCTS NV k013497 11/09/2001
ff450 plus fundus camera and visupac digital image archiving system, or ff450 plus visupac system CARL ZEISS JENA GMBH k011877 09/26/2001
fibiocore EST. ANTHOGYR k020431 07/03/2002
fistulok fistula needle protection DIASOL, INC. k010958 05/18/2001
flexible pediatric cystoureteroscope, model aur- 735 CIRCON VIDEO k012929 11/19/2001

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