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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 K090341
Device Name MICHIGAN CRANIAL RESHAPING ORTHOSIS
Applicant
DANMAR PRODUCTS, INC.
537 FORT DEARBORN STREET
DEARBORN,  MI  48124
Applicant Contact KAY FULLER, RAC
Correspondent
DANMAR PRODUCTS, INC.
537 FORT DEARBORN STREET
DEARBORN,  MI  48124
Correspondent Contact KAY FULLER, RAC
Regulation Number882.5970
Classification Product Code
MVA  
Subsequent Product Code
OAN  
Date Received02/10/2009
Decision Date 01/06/2010
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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