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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 K232509
Device Name Accu-Chek Safe-T-Pro Uno Lancing Device
Applicant
Roche Diabetes Care, Inc.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact Kacia Mills
Correspondent
Roche Diabetes Care, Inc.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact Kacia Mills
Regulation Number878.4850
Classification Product Code
FMK  
Date Received08/18/2023
Decision Date 11/13/2023
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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