FDA 510(k), K222689, Mallya Injection Pen Adapter (Mallya® for Solostar®)

FDA 510(k), K222689, Mallya Injection Pen Adapter (Mallya® for Solostar®)

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510(K) Number: K222689
Device Name: Mallya Injection Pen Adapter (Mallya® for Solostar®)
Manufacturer: Alexia Garin
Device Classification Name: Injection Data Capture Device
Regulation Number: QOG
Classification Product Code: KXA
Date Received: 09/06/2022
Decision Date: 12/05/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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