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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 K132547
Device Name ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
Applicant
MONARCH MEDICAL TECHNOLOGIES
3457 CHISWICK COURT
SILVER SPRING,  MD  20906
Applicant Contact ANN A GRAHAM
Correspondent
MONARCH MEDICAL TECHNOLOGIES
3457 CHISWICK COURT
SILVER SPRING,  MD  20906
Correspondent Contact ANN A GRAHAM
Regulation Number868.1890
Classification Product Code
NDC  
Date Received08/13/2013
Decision Date 04/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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