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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, drug dose
510(k) Number K071713
Device Name CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR
Applicant
MEDICAL DECISIONS NETWORK
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact JONATHAN KAHAN
Correspondent
MEDICAL DECISIONS NETWORK
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN KAHAN
Regulation Number868.1890
Classification Product Code
NDC  
Date Received06/22/2007
Decision Date 10/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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