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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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mri line marker I.Z.I. CORP. k014022 03/04/2002
temporary crown and bridge material J. MORITA USA, INC. k020157 03/04/2002
accolade tmzf ha 132 degree size 0 hip stem HOWMEDICA OSTEONICS CORP. k020572 03/04/2002
diastat total anti-cardiolipin, model fcar 100t AXIS-SHIELD DIAGNOSTICS, LTD. k020156 03/06/2002
non-eugenol temporary cement J. MORITA USA, INC. k020158 03/07/2002
biotech manual wheelchair, a1000 super sport wheelchair TAIWAN ARMADA ENTERPRISE CO., LTD. k020188 03/08/2002
vistitome 20-10 microkeratome BIOVISION AG k014000 03/11/2002
playtex deodorant tampons, model 34902 PLAYTEX PRODUCTS, INC. k020201 03/12/2002
playtex deodorant tampons, model 34702 PLAYTEX PRODUCTS, INC. k020202 03/12/2002
pisces plus (dw286 c) IVOCLAR VIVADENT, INC. k020183 03/13/2002

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