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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Use Blood Lancet For Single Patient Use Only
510(k) Number K232912
Device Name Facet Aurora Reusable Lancet Base
Applicant
Facet Technologies, LLC
3900 N. Commerce Dr.
Atlanta,  GA  30344
Applicant Contact James Bonds
Correspondent
Facet Technologies, LLC
3900 N. Commerce Dr.
Atlanta,  GA  30344
Correspondent Contact James Bonds
Regulation Number878.4850
Classification Product Code
QRL  
Subsequent Product Code
QRK  
Date Received09/19/2023
Decision Date 01/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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