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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 K200443
Device Name EndoTool IV 1.10
Monarch Medical Technologies, LLC
4400 Stuart Andrew Blvd, Suite N
Charlotte,  NC  28217
Applicant Contact Ann Marie Gaitan
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number868.1890
Classification Product Code
Date Received02/24/2020
Decision Date 03/17/2020
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 Yes
Combination Product No