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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 K153670
Device Name Genteel Lancing Device
Applicant
Genteel, LLC
4011 Livingstone St.
Midland,  TX  79707
Applicant Contact Christopher Jacobs
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Mark DuVal
Regulation Number878.4850
Classification Product Code
FMK  
Date Received12/21/2015
Decision Date 05/12/2016
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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