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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Limb Brace
510(k) Number K052771
Device Name SENSOR WALK
Applicant
Otto Bock Healthcare LP
2 Carlson Pwy. Suite 100
Minneapolis,  MN  55447 -4467
Applicant Contact BILL CLOVER
Correspondent
Otto Bock Healthcare LP
2 Carlson Pwy. Suite 100
Minneapolis,  MN  55447 -4467
Correspondent Contact BILL CLOVER
Regulation Number890.3475
Classification Product Code
IQI  
Date Received09/30/2005
Decision Date 05/03/2006
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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