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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
Predetermined Change
Control Plan Authorized		 No
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