FDA 510(k), K203835, MIS Solution

FDA 510(k), K203835, MIS Solution

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510(K) Number: K203835
Device Name: MIS Solution
Manufacturer: Courtney Narain
Device Classification Name: Dressing, Wound, Drug
Regulation Number: FRO
Classification Product Code: KXA
Date Received: 12/30/2020
Decision Date: 04/23/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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