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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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resusci inflate-a-shield cpr barrier LAERDAL MEDICAL CORP. k001742 10/06/2000
respirtech pro-o2c, model 2200 and respirtech pro, model 2000 VORTRAN MEDICAL TECHNOLOGY 1, INC. k001430 07/05/2000
respironics silhouette nasal mask, models 1003224 and 1003223 RESPIRONICS, INC. k000705 09/08/2000
reprocessed trocars ASCENT HEALTHCARE SOLUTIONS k070059 10/02/2007
reprocessed disposable trocars MEDICAL DEVICE SERVICES k022743 10/09/2002
renew ls-2 BISCO, INC. k003361 11/28/2000
renegade hi-flo microcatheter BOSTON SCIENTIFIC CORP. k000177 04/07/2000
renaflo ii hf 2000 hemofilter MINNTECH CORP. k000028 04/04/2000
release nf antibacterial foley catheter, antibacterial personal catheter ROCHESTER MEDICAL CORP. k001143 07/07/2000
reflection constrained liner SMITH & NEPHEW, INC. k021803 12/19/2002

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