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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 K222539
Device Name Facet Blood Lancets
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
FMK  
Date Received08/22/2022
Decision Date 11/18/2022
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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