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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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tc-plus solution knee PLUS ORTHOPEDICS k000666 10/13/2000
vision 9000 phased array torso coil USA INSTRUMENTS, INC. k002482 10/17/2000
renu multiplus multi-purpose disinfecting solution BAUSCH & LOMB, INC. k002823 10/17/2000
xps nitro system XOMED, INC. k002828 10/17/2000
precisionedge-acc, precisionedge-acs, precisionedge-lsk, and precisionedge-cb microkeatome blades SURGICAL SPECIALTIES CORP. k002849 10/18/2000
macroporemx mandibular fixation system MACROPORE BIOSURGERY, INC. k000696 10/19/2000
jetcan huber neeedle set PFM PRODUKTE FUR DIE MEDIZIN AG k002471 10/19/2000
biomesh p1 and biomesh plug and patch COUSIN BIOTECH S.A.R.L k002479 10/19/2000
solution administration sets with capless luer activated valve BAXTER HEALTHCARE CORP. k003225 10/19/2000
disposbable powdered vinyl synthetic exam gloves, white color SHANGHAI PM PLASTICS ENTERISE CO., LTD. k002814 10/20/2000

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