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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 K030669
Device Name PROVIDENCE MOLDING HELMET
Applicant
NORTHEAST ORTHOTICS AND PROTHETICS, INC.
170 MACKLIN STREET
CRANSTON,  RI  02920
Applicant Contact D. BARRY MCCOY
Correspondent
NORTHEAST ORTHOTICS AND PROTHETICS, INC.
170 MACKLIN STREET
CRANSTON,  RI  02920
Correspondent Contact D. BARRY MCCOY
Regulation Number882.5970
Classification Product Code
MVA  
Date Received03/03/2003
Decision Date 07/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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