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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 K013458
Device Name CRANIAL HELMET
Applicant
CHILDREN'S HOSPITAL
5353 WAYZATA BLVD.
MINNEAPOLIS,  MN  55416 -1334
Applicant Contact CONNIE FICKLIN
Correspondent
CHILDREN'S HOSPITAL
5353 WAYZATA BLVD.
MINNEAPOLIS,  MN  55416 -1334
Correspondent Contact CONNIE FICKLIN
Regulation Number882.5970
Classification Product Code
MVA  
Date Received10/18/2001
Decision Date 10/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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