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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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rotachrom heparin and sta -rotachrom heparin Diagnostica-Stago k010455 06/07/2001
rx herculink 14 biliary stent system, models 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100 Guidant Corp. k001224 05/17/2000
sandhill unitip catheter pressure sensor, model k 5251-l3-0026 Sandhill Scientific, Inc. k002427 06/22/2001
select seed i-125 Nucletron Corp. k002429 02/02/2001
sensititre susceptibility plates-additional antimicrobics Trek Diagnostic Systems, Inc. k003834 02/23/2001
seragard injection patch Platinum Services, Inc. k001240 06/21/2000
sh-1 Delta Medical Industries k770344 05/09/1977
shapeable doppler flow probe Cook Vascular, Inc. k002958 12/18/2001
shield, dental x-ray, protective Worldwide Dental, Inc. k770407 03/15/1977
sigmoidoscope, disposable, model #53125 Welch Allyn, Inc. k770291 02/18/1977

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