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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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avid-nit plastic hub lutz epidural needle,model rp2035l, avid-nit metal hub lutz epidural needle, model rm2035l AVID N.I.T., INC. k013231 12/03/2001
cybercases by bausch & lomb BAUSCH & LOMB, INC. k013232 11/20/2001
microjet crono CANE SRL k013234 04/26/2002
modification to synchron control BECKMAN COULTER, INC. k013235 10/16/2001
luxabite DMG USA, INC. k013236 10/17/2001
statusblue DMG USA, INC. k013237 10/22/2001
comfortcare compression support with magnets comfortcare magnetic insoles MED GEN, INC. k013239 11/20/2001
arndt emergency cricothyrotomy catheter set COOK, INC. k013241 02/21/2002
amsco harmony surgical lighting and media system STERIS Corporation k013242 12/13/2001
coaptite laryngeal augmentation system 1cc & o.5cc, models 0008021-1, 0008022-1 BIOFORM, INC. k013243 01/09/2002

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