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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Use Blood Lancet For Single Patient Use Only
510(k) Number K221072
Device Name TRUEdraw Lancing Device, Mini Lancing Device
Applicant
Trividia Health
2400 NW 55th Ct.
Fort Lauderdale,  FL  33309
Applicant Contact Jacqueline Davis
Correspondent
Trividia Health
2400 NW 55th Ct.
Fort Lauderdale,  FL  33309
Correspondent Contact Jacqueline Davis
Regulation Number878.4850
Classification Product Code
QRL  
Date Received04/12/2022
Decision Date 10/18/2022
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
Predetermined Change
Control Plan Authorized		 No
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