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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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r & d 4k retic R&D Systems, Inc. k010470 05/11/2001
afocus electropysiology catheter system, models 81550, 81567, 81568, 81569 Irvine Biomedical, Inc. k010471 06/06/2001
patient dose verification system, model tn-rd-50 Thomson & Nielsen Electronics, Ltd. k010472 05/08/2001
sparrowhawk disposable Atc Technologies, Inc. k010473 06/06/2001
uric acid test, bmc autoflo Boehringer Mannheim Corp. k770272 03/01/1977
test, ammonia, bmc reagentset Boehringer Mannheim Corp. k770273 03/01/1977
electrotherapy apparatus e.t. 720 Fort & Assoc. k770276 03/09/1977
cholesterol standards Worthington Biochemical Corp. k770277 03/01/1977
spectrophotometers, infrared models x99 The Perkin-Elmer Corp. k770278 03/10/1977
monitor, portable, part #431-010 Mennen Greatbatch Electonics k770279 02/24/1977

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