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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alternate Controller Enabled Insulin Infusion Pump
510(k) Number K234027
Device Name embecta Insulin Delivery System
Applicant
Embecta Medical I, LLC
200 Bulfinch Drive, Suite 100
Andover,  MA  01810
Applicant Contact Andrew Harrell
Correspondent
Embecta Medical I, LLC
200 Bulfinch Drive, Suite 100
Andover,  MA  01810
Correspondent Contact Andrew Harrell
Regulation Number880.5730
Classification Product Code
QFG  
Date Received12/20/2023
Decision Date 08/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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