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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 K180568
Device Name KidCap
Applicant
Eastern Cranial Affiliates, LLC
10523 Main Street
Fairfax,  VA  22030
Applicant Contact Joseph Terpenning
Correspondent
Eastern Cranial Affiliates, LLC
10523 Main Street
Fairfax,  VA  22030
Correspondent Contact Joseph Terpenning
Regulation Number882.5970
Classification Product Code
MVA  
Date Received03/05/2018
Decision Date 10/16/2018
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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