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FDA 510(k) Applications for Medical Device Product Code "SAH"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K243213
GI Windows Inc.
Self-Forming Magnet (FLEX SFM)
01/29/2025
K243482
GI Windows Inc.
Self-Forming Magnet (Flexagon)
06/11/2025
DEN240013
GT Metabolic Solutions, Inc.
MagDI System
07/02/2024
K242086
GT Metabolic Solutions, Inc.
MagDI System (MAG-01, DS-01)
10/24/2024
K243359
GT Metabolic Solutions, Inc.
MagDI System (MAG-02, DS-01)
02/28/2025
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