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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Cranial
510(k) Number K111247
Device Name CRANIAL REMOLDING ORTHOSIS
Applicant
Orthotic Care Services, Llp
360 Sherman St., Suite 299
St.Paul,  MN  55102
Applicant Contact SCOTT HINSHON
Correspondent
Orthotic Care Services, Llp
360 Sherman St., Suite 299
St.Paul,  MN  55102
Correspondent Contact SCOTT HINSHON
Regulation Number882.5970
Classification Product Code
MVA  
Date Received05/03/2011
Decision Date 08/15/2011
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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