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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 K223352
Device Name Tenderfoot
Applicant
Accriva Diagnostics, Inc.
6260 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Wenni Haley
Correspondent
Accriva Diagnostics, Inc.
6260 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Wenni Haley
Regulation Number878.4850
Classification Product Code
FMK  
Date Received11/02/2022
Decision Date 03/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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