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FDA 510(k) Applications Submitted by Shaylee Masilunas
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150638
03/11/2015
AF541 SE Full Face Mask
Respironics, Inc.
K150639
03/11/2015
AF541 EE Full Face Mask
RESPIRONICS, INC.
K140980
04/16/2014
TI NASAL MASK
RESPIRONICS, INC.
K151120
04/27/2015
Simple T Pediatric Nasal Mask
RESPIRONICS, INC.
K183468
12/14/2018
Revive Reusable Bladder Support
Rinovum Subsidiary 2, LLC
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