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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
Applicant
Monarch Medical Technologies, LLC
4400 Stuart Andrew Blvd, Suite N
charlotte,  NC  28217
Applicant Contact ann marie gaitan
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact prithul bom
Regulation Number868.1890
Classification Product Code
NDC  
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
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