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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K071113
Device Name RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053
Applicant
Restorative Therapies, Inc.
907 S. Lakewood Ave.
Baltimore,  MD  21224
Applicant Contact ANDREW BARRISKILL
Correspondent
Restorative Therapies, Inc.
907 S. Lakewood Ave.
Baltimore,  MD  21224
Correspondent Contact ANDREW BARRISKILL
Regulation Number882.5810
Classification Product Code
GZI  
Date Received04/20/2007
Decision Date 07/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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