FDA 510(k), K221131, Tasso+

510(K) Number: K221131
Device Name: Tasso+
Manufacturer: Trish Kan Brown
Device Classification Name: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Regulation Number: FMK
Classification Product Code: KXA
Date Received: 04/18/2022
Decision Date: 08/12/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery

206 pages (1,009 of 1,215 original pages are fully redacted)