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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 K021594
Device Name COPC BAND
Applicant
CENTER FOR ORTHOTIC AND PROSTHETIC CARE,LLC
2525 NORTH TENTH ST. #804
ARLINGTON,  VA  22201
Applicant Contact JOSEPH TERPENNING
Correspondent
CENTER FOR ORTHOTIC AND PROSTHETIC CARE,LLC
2525 NORTH TENTH ST. #804
ARLINGTON,  VA  22201
Correspondent Contact JOSEPH TERPENNING
Regulation Number882.5970
Classification Product Code
MVA  
Date Received05/15/2002
Decision Date 11/13/2003
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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