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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Breast Milk Macronutrients Test System
510(k) Number K234088
Device Name Emily's Care Nourish Test System (Model 1)
Applicant
Lactation Lab Inc.
2611 Palm Avenue
Manhattan Beach,  CA  90266
Applicant Contact Stephanie Canale
Correspondent
Lactation Lab Inc.
2611 Palm Avenue
Manhattan Beach,  CA  90266
Correspondent Contact Stephanie Canale
Classification Product Code
QEI  
Date Received12/22/2023
Decision Date 05/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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