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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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s/5 compact anesthesia monitor with s-00a05, s-00a06. l-00a07, l00a08 Datex-Ohmeda, Inc. k002478 10/05/2000
s.c.m.t. perforator Salt Creek Medical Technologies k871087 03/23/1987
rx everest Jeneric/Pentron, Inc. k001051 04/28/2000
rumbar drainage system Phoenix Biomedical Corp. k000514 05/10/2000
rubicon prothrombin time monitoring system Lifescan, Inc. k001699 05/15/2001
rubella microassay Diamedix Corp. k864602 04/14/1987
rsvp systems, series i, bed-patient monitor Tactilitics, Inc. k864827 01/21/1987
roughrider aurora manual wheelchair Roughrider America, LLC k200715 06/24/2022
rosenthal needle (disp.) adt bone marrow A.D.T. Lab Industries k800412 04/28/1980
rlp-cholesterol immunoseparation assay Otsuka Pharmaceutical Co., Ltd. k001032 07/24/2000

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