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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 K002410
Device Name FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE
Applicant
Dysphagia, LLC
3011 Kersdale Rd.
Cleveland,  OH  44124
Applicant Contact MARCY FREED
Correspondent
Dysphagia, LLC
3011 Kersdale Rd.
Cleveland,  OH  44124
Correspondent Contact MARCY FREED
Regulation Number890.5850
Classification Product Code
IPF  
Date Received08/07/2000
Decision Date 06/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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