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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 K242664
Device Name gentleheel® Adult Incision Device
Applicant
Gri-Alleset, Inc.
4142 Industry Way
Flowery Branch,  GA  30542
Applicant Contact Marty Paugh
Correspondent
Regulatory Resources Group, Inc.
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Correspondent Contact Julie Stephens
Regulation Number878.4850
Classification Product Code
FMK  
Date Received09/04/2024
Decision Date 11/05/2024
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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