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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 K220917
Device Name gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
Applicant
GRI-Alleset, Inc.
4142 Industry Way
Flowery Branch,  GA  31403 1
Applicant Contact Marty D 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 Received03/30/2022
Decision Date 05/18/2022
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
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