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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 K242680
Device Name LetsGetChecked Impress
Applicant
Privapath Diagnostics Ltd (Dba Letsgetchecked)
Unit 1, Northern Cross Business Park
North Rd., Dublin 11
Dublin,  IE D11XT26
Applicant Contact Karen Walsh
Correspondent
Privapath Diagnostics Ltd (Dba Letsgetchecked)
Unit 1, Northern Cross Business Park
North Rd., Dublin 11
Dublin,  IE D11XT26
Correspondent Contact Karen Walsh
Regulation Number878.4850
Classification Product Code
FMK  
Date Received09/06/2024
Decision Date 01/13/2025
Decision SE - With Limitations (SESU)
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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