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FDA 510(k) Applications Submitted by Thomas W Brown
FDA 510(k) Number
Submission Date
Device Name
Applicant
K193577
12/23/2019
SleepRight ProRx Custom Dental Guard
Splintek, Inc.
K212706
08/26/2021
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
Splintek, Inc.
K212767
08/31/2021
SleepRight Select-Comfort Dental Guard
Splintek, Inc.
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