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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 K012920
Device Name MOLDED CRANIAL HELMET
Applicant
FAIRVIEW ORTHOPEDIC LABORATORY
220 S.6TH ST.
MINNEAPOLIS,  MN  55402 -1498
Applicant Contact ROSS C D'EMANUELE
Correspondent
FAIRVIEW ORTHOPEDIC LABORATORY
220 S.6TH ST.
MINNEAPOLIS,  MN  55402 -1498
Correspondent Contact ROSS C D'EMANUELE
Regulation Number882.5970
Classification Product Code
MVA  
Date Received08/30/2001
Decision Date 11/28/2001
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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