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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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synergy head/neck coil PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. k001331 06/09/2000
synthes (usa) locking proximal plating (l-ptp) system SYNTHES (USA) k002361 10/31/2000
synthes (usa) oribital mesh plates SYNTHES (USA) k001311 06/20/2000
synthes (usa) resorbable tack system SYNTHES (USA) k000560 01/09/2001
synthes (usa) wrist fusion plates (wfp) SYNTHES (USA) k000558 04/14/2000
synthes anterior cslp system SYNTHES SPINE k000536 03/15/2000
synthes calcium sulfate bone void filler pellets (synthes pellets) SYNTHES (USA) k002362 11/01/2000
synthetic (white) vinal powdered patient examination gloves SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD k000166 02/22/2000
synthetic powder free (yellow) vinyl patient examination gloves SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD. k001834 06/30/2000
talon balloon dilation catheter BOSTON SCIENTIFIC CORP. k000798 06/08/2000

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