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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 K201619
Device Name EndoTool IV System
Applicant
Monarch Medical Technologies, LLC
4400 Stuart Andrew Blvd, Suite N
Charlotte,  NC  28217
Applicant Contact Ann Marie Gaitan
Correspondent
Medical Device Academy
4400 Stuart Andrew Blvd., Suite N
Charlotte,  NC  28217
Correspondent Contact Ann Marie Gaitan
Regulation Number868.1890
Classification Product Code
NDC  
Date Received06/15/2020
Decision Date 08/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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