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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 K221131
Device Name Tasso+
Applicant
Tasso, Inc.
1631 15th Ave W, Suite 105
Seattle,  WA  98119
Applicant Contact Trish Kan Brown
Correspondent
Tasso, Inc.
1631 15th Ave W, Suite 105
Seattle,  WA  98119
Correspondent Contact Trish Kan Brown
Regulation Number878.4850
Classification Product Code
FMK  
Date Received04/18/2022
Decision Date 08/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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