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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 K142918
Device Name EndoTool SubQ
Applicant
MONARCH MEDICAL TECHNOLOGIES
2137 SOUTH BLVD.
SUITE 300
CHARLOTTE,  NC  28203
Applicant Contact STUART LONG
Correspondent
CERTIFIED COMPLIANCE SOLUTIONS
11665 AVENA PLACE, SUITE 203
SAN DIEGO,  CA  92128
Correspondent Contact AL PACHECO
Regulation Number868.1890
Classification Product Code
NDC  
Date Received10/07/2014
Decision Date 04/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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