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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Foot Drop
510(k) Number K073521
Device Name MUSMATE WALKING AID
Applicant
Musmate, Ltd.
4 Ford Rd.
Peasedown St. John
Bath, Somerset,  GB BA2 8DG
Applicant Contact ANDREW JAMES WYND
Correspondent
Musmate, Ltd.
4 Ford Rd.
Peasedown St. John
Bath, Somerset,  GB BA2 8DG
Correspondent Contact ANDREW JAMES WYND
Regulation Number890.3475
Classification Product Code
OHI  
Date Received12/14/2007
Decision Date 02/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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