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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lancet, blood
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
minneapolis,  MN  55402
Correspondent Contact mark duval
Regulation Number878.4800
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
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