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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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swivel elbow ENGINEERED MEDICAL SYSTEMS k000215 05/26/2000
synamps (32-64 channels), esi synamps (65-128 channels), esi synamps (129-256 channels) NEURO SCAN LABS k001324 07/11/2000
synergy head/neck coil PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. k001331 06/09/2000
synthes (usa) locking condylar plate (lcp) system SYNTHES (USA) k000066 03/15/2000
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 scalloped distal tibia plate SYNTHES (USA) k001793 08/17/2000
synthetic (white) vinal powdered patient examination gloves SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD k000166 02/22/2000

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