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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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ultrasim ct system PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. k001088 06/22/2000
hanwella latex patient exam. gloves powder-free HANWELLA RUBBER PRODUCTS LTD. k000351 06/23/2000
sulzer orthopedics ms-30 femoral stem SULZER ORTHOPEDICS, INC. k001078 06/23/2000
plain and chromic gut absorbable surgical sutures usp CP MEDICAL k001299 06/23/2000
infinity amylase reagent (procedure no. 580/568) SIGMA DIAGNOSTICS, INC. k001569 06/26/2000
modification to nc-stat NEUROMETRIX, INC. k000565 06/27/2000
mac-lab system and cardiolab ep system GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN k001305 06/27/2000
elecsys insulin calcheck ROCHE DIAGNOSTICS CORP. k001846 06/28/2000
spine system evolution AESCULAP, INC. k001080 06/29/2000
normocarb sterile bicarbonate renal dialysis NOVEX PHARMA k001059 06/30/2000

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