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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 K220849
Device Name Accu-Chek Safe-T-Pro Plus Lancing Device
Applicant
Roche Diabetes Care, Inc.
9115 Hague Rd.
Indianpolis,  IN  46256
Applicant Contact Jason Lee
Correspondent
Roche Diabetes Care, Inc.
9115 Hague Rd.
Indianpolis,  IN  46256
Correspondent Contact Jason Lee
Regulation Number878.4850
Classification Product Code
FMK  
Date Received03/23/2022
Decision Date 05/19/2022
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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