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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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coulter accu-zyme ii gpt reagent COULTER ELECTRONICS, INC. k790522 05/01/1979
mevatron 67 SIEMENS MEDICAL LABORATORIES, INC. k790688 04/23/1979
one-way valve AIRLIFE, INC. k790151 03/12/1979
anametric tibial component metal tray HOWMEDICA CORP. k790348 03/06/1979
dialyzer, magniflo 100 parallel plate ERIKA, INC. k781966 02/21/1979
pacing leads model ul-811 and ul-813 PACESETTER SYSTEMS k781776 10/27/1978
gram stain kit BIOSCIENTIFIC k781584 10/10/1978
stat ultra violet liquid BECKMAN INSTRUMENTS, INC. k781432 10/03/1978
chair, vestibular, rotary, comput. CONTRAVES k781268 08/14/1978
o2 connector DIEMOLDING CORP. k780750 07/27/1978

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