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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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modification to: hydrocoil embolic system (hes) MICROVENTION, INC. k041551 07/07/2004
stryker maestro system STRYKER CORP. k041754 09/07/2004
composite/compomer repair kit DMG USA, INC. k041960 08/30/2004
heart rate turbulence analysis technologies GE MEDICAL SYST. INFORMATION TECHNOLOGIES k042148 12/03/2004
syringe grip for the avonex pre-filled syringe BIOGEN k042314 11/22/2004
kurz clip piston mvp, model 1006 711-13/0.4 mm + 1006 761-63/0.6mm HEINZ KURZ GMBH MEDIZINTECHNIK k042503 10/01/2004
updated slip urology introducer sheath PERCUTANEOUS SYSTEMS, INCORPORATED k042531 02/01/2005
cosmedent pit & fissure sealant COSMEDENT, INC. k042823 12/01/2004
dynatron ibox iontophoresis device DYNATRONICS CORP. k043047 01/07/2005
modification to roche elecsys folate ii immunoassay ROCHE DIAGNOSTICS CORP. k043318 12/23/2004

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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