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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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castle peracetic acid biological indicator kit GETINGE/CASTLE, INC. k020205 06/24/2002
intraoral camera me-15 DENT CORP. RESEARCH & DEVELOPMENT k020206 04/11/2002
sas value hcg SA SCIENTIFIC, INC. k020438 03/08/2002
status hcg serum/urine PRINCETON BIOMEDITECH CORP. k020439 05/23/2002
newcor SIEMENS MEDICAL SYSTEMS, INC. k020440 12/03/2002
emit ii plus monoclonal cocaine metabolite assay DADE BEHRING, INC. k020441 03/28/2002
the electrode store surface (cutaneous) electrode for emg THE ELECTRODE STORE, INC. k020445 05/10/2002
modification to straight-in bone screw fixation system AMERICAN MEDICAL SYSTEMS, INC. k020446 03/13/2002
mityvac merlin, model 10027 PRISM ENTERPRISES, INC. k020447 04/12/2002
static cranioplasty orthosis EASTERN CRANIAL AFFILIATES k020448 04/12/2002

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