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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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the tosca anterior cervical plate system SIGNUS MEDIZINTECHNIK GMBH k043082 11/23/2004
size 1 triathlon cruciate retaining (cr) tibial insert HOWMEDICA OSTEONICS CORP k042883 11/23/2004
syringe grip for the avonex pre-filled syringe BIOGEN k042314 11/22/2004
imalux niris imaging system IMALUX CORPORATION k042894 11/19/2004
3viseon 3MENSIO MEDICAL IMAGING BV k043097 11/19/2004
architect ca 125 ii assay FUJIREBIO DIAGNOSTICS, INC. k042731 11/19/2004
amplife digital infrared ear thermometer, model e101 AMPLIFE CORPORATION k042906 11/19/2004
modification to dimension nt-probnp flex reagent cartridge method DADE BEHRING, INC. k042347 11/19/2004
autobahn tissue closure device and disposable cartridge ETHICON ENDO-SURGERY, INC. k042897 11/19/2004
synthes (usa) neuro plate and screw system SYNTHES (USA) k042365 11/18/2004

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