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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 K010273
Device Name CRANIAL MOLDING ORTHOSIS
Applicant
ORTHOTIC SOLUTIONS, INC.
2802 MERRILEE DR.
SUITE 100
fairfax,  VA  22031
Applicant Contact joseph f terpenning
Correspondent
ORTHOTIC SOLUTIONS, INC.
2802 MERRILEE DR.
SUITE 100
fairfax,  VA  22031
Correspondent Contact joseph f terpenning
Regulation Number882.5970
Classification Product Code
MVA  
Date Received01/29/2001
Decision Date 04/25/2001
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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