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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 K211160
Device Name EndoTool SubQ 2.1
Applicant
Monarch Medical Technologies, LLC
4400 Stuart Andrew Blvd., Suite N
Charlotte,  NC  28217
Applicant Contact Ann Marie Gaitan
Correspondent
Monarch Medical Technologies, LLC
1924 Cleveland Ave., Suite 201
Charlotte,  NC  28203
Correspondent Contact Christophe Mallard
Regulation Number868.1890
Classification Product Code
NDC  
Date Received04/19/2021
Decision Date 10/28/2021
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
Predetermined Change
Control Plan Authorized		 No
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