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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 N. Tenth St. #804
Arlington,  VA  22201
Applicant Contact JOSEPH TERPENNING
Correspondent
Center For Orthotic and Prosthetic Care,Llc
2525 N. 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
Predetermined Change
Control Plan Authorized		 No
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