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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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0.9% sodium chloride vasculat access device AVITRO LLC. k000632 10/19/2000
300 pv complete electrotherapy system EMPI k021100 06/18/2002
3i locater abutment system IMPLANT INNOVATIONS, INC. k012911 09/28/2001
7.0 fr. endobronchial blocker COOK, INC. k021920 08/14/2002
aa-1 system NEUROVISION, INC. k012530 08/31/2001
aart silicone sheeting AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. k022223 08/08/2002
ab belt THE DEZAC GROUP k020427 09/13/2002
ab belt pro THE DEZAC GROUP k020429 09/13/2002
abi vest airway clearance system ADVANCED RESPIRATORY k012928 10/09/2001
accolade c femoral component HOWMEDICA OSTEONICS CORP. k002320 09/14/2000

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