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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K223370
Device Name NeatNick Heel Safety Lancet
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
FMK  
Date Received11/04/2022
Decision Date 02/13/2023
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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