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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 K222801
Device Name Safety Lancet
Sarstedt AG & CO KG
Sarstedtstrasse 1
Nuembrecht,  DE 51588
Applicant Contact Jochen Hoffman
1025 St. James Church Road
Newton,  NC  28658
Correspondent Contact Susan Smith
Regulation Number878.4850
Classification Product Code
Date Received09/16/2022
Decision Date 01/25/2023
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