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Medical equipment / Enteral feeding / Food law / Pharmacology / Medical device / Federal Food / Drug / and Cosmetic Act / Feeding tube / Premarket approval / Nasogastric intubation / Medicine / Health / Food and Drug Administration


Syncro-Blue Tube, The Magnetically Guided Enteral Feed Tube SECTION[removed]K) SUMMARY
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Document Date: 2011-09-26 00:30:14

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File Size: 140,75 KB

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Company

KIIO0005 Trade / Syncro Medical Innovations Inc. / Principal Consultant Keystone Regulatory Services LLC / Number Syncro Medical Innovations Inc. / R-AC / /

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IndustryTerm

announcements concerning your device / enteral feeding solutions / marketed predicate devices / manufacturing practice / marketed predicate device / guidance tool / /

MedicalCondition

malnutrition / burn / disease / /

MedicalTreatment

enteral feeding / /

Organization

office of Comnpliance / Center for Devices and Radiological Health / office of Device Evaluation / office of Surveillance / Division of Reproductive / FDA / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Postmnarket Surveillance / Reproductive / Castro-Renal / and Urological Devices Office / /

Person

William G. McLain / Gabriel Blue Tube Magnetically Guided / /

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Position

Submission Correspondent / President / physician / rt / /

Technology

radiation / http / MRI / /

URL

www.fda.goN / http /

SocialTag