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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 K003630
Device Name DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
Applicant
DANMAR PRODUCTS, INC.
221 JACKSON INDUSTRIAL DR.
ANN ARBOR,  MI  48103
Applicant Contact KAREN A LINDNER
Correspondent
DANMAR PRODUCTS, INC.
221 JACKSON INDUSTRIAL DR.
ANN ARBOR,  MI  48103
Correspondent Contact KAREN A LINDNER
Regulation Number882.5970
Classification Product Code
MVA  
Date Received11/24/2000
Decision Date 05/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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