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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 K141321
Device Name GLUCOSTABILIZER INSULIN DOSING CALCULATOR
Applicant
MEDICAL DECISION NETWORK
2657 CORALBERRY PL
CHARLOTTESVILLE,  VA  22911
Applicant Contact JANE KEATHLEY
Correspondent
MEDICAL DECISION NETWORK
2657 CORALBERRY PL
CHARLOTTESVILLE,  VA  22911
Correspondent Contact JANE KEATHLEY
Regulation Number868.1890
Classification Product Code
NDC  
Date Received05/20/2014
Decision Date 09/15/2014
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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