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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 K003035
Device Name CLARREN HELMET
Applicant
CHILDREN'S HOSPITAL & MEDICAL CENTER
1301 K STREET, N.W.
SUITE 1100
WASHINGTON,  DC  20005
Applicant Contact DAVID J BLOCH
Correspondent
CHILDREN'S HOSPITAL & MEDICAL CENTER
1301 K STREET, N.W.
SUITE 1100
WASHINGTON,  DC  20005
Correspondent Contact DAVID J BLOCH
Regulation Number882.5970
Classification Product Code
MVA  
Date Received09/28/2000
Decision Date 06/06/2001
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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