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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 K060032
Device Name RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053
Applicant
RESTORATIVE THERAPIES INC.
2363 BOSTON ST.
BALTIMORE,  MD  21224
Applicant Contact ANDREW BARRISKILL
Correspondent
RESTORATIVE THERAPIES INC.
2363 BOSTON ST.
BALTIMORE,  MD  21224
Correspondent Contact ANDREW BARRISKILL
Regulation Number882.5810
Classification Product Code
GZI  
Date Received01/05/2006
Decision Date 03/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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