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Medical equipment / Glucommander / Insulin pump / Eli Lilly and Company / Blood tests / Insulin resistance / Insulin / Blood sugar / Medical device / Medicine / Endocrine system / Diabetes


Document Date: 2006-07-27 12:18:10

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City

Washington / Camas / /

Company

Medtronic / CollaborativeMed LLC / Phillips Drug Calculator Dose Computation Operations Algorithms Software / K061110 Trade / Lee Responsible Third Party Official Underwriters Laboratories Incorporated / CollaborativeMed LLC C / /

Event

FDA Phase / /

Facility

General Hospital / /

/

IndustryTerm

announcements concerning your device / manufacturing practice requirements / food intake / marketed predicate devices / computer-based software application / manufacturing practice / healthcare / software program / Internet address htt / cleared predicate devices / mathematical algorithm / /

MedicalCondition

insulin allergies / hyperglycemia / /

MedicalTreatment

Insulin delivery / intravenous infusion / /

Organization

Division of Anesthesiology / Food and Drug Administration / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / Infection Control and Dental Devices Office / General Hospital / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / LLC C/O Ms. Michelle S. Lee Responsible Third Party / /

Person

Robert Booth / Chiu Lin / Greenville / /

/

Position

Director / physician / /

Product

Federal Food / /

ProvinceOrState

Washington / /

Technology

radiation / mathematical algorithm / /

URL

www.fda.gov/cdrh/industry/support/index.html / /

SocialTag