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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, muscle, powered
510(k) Number K092202
Device Name ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT
Original Applicant
ESWALLOW USA
8870 ravello court
naples,  FL  34114
Original Contact daniel kamm
Regulation Number890.5850
Classification Product Code
IPF  
Date Received07/22/2009
Decision Date 02/10/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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