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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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altaire magnetic resonance imaging system HITACHI MEDICAL SYSTEMS AMERICA, INC. k021751 08/15/2002
fp(hexafocon a)rgp contact lens spherical/asp(hexafocon a)rgp contact lens aspherical LUCID KOREA CO., LTD k021752 10/11/2002
e-care infared ear thermometer, model lct-200 E-CARE TECHNOLOGY CORPORATION k021753 08/06/2002
apex medical digital ems ts1311, ts1312 APEX MEDICAL CORP. k021754 06/28/2002
apex medical digital tens ts1211, ts1212 APEX MEDICAL CORP. k021755 06/12/2002
welch allyn abpm 6100 WELCH ALLYN, INC. k021756 06/27/2002
perifix catheter connector B. BRAUN MEDICAL, INC. k022019 08/01/2002
justwo model tme-601 root apex locator TOEI ELECTRIC CO., LTD. k022020 07/02/2002
vital scientific aptt, aptt & quikcoag aptt VITAL SCIENTIFIC N.V. k022021 11/01/2002
jostra vent catheters, models lv & hkv JOSTRA AG k022022 09/11/2002

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