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Devices@FDA

 
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Device Classification Name equipment, traction, powered
510(k) NumberK033231
Device NameSPINA SYSTEM
Applicant
NORTH AMERICAN MEDICAL CORP (NAM)
3350 riverwood pkwy.
suite 1900
atlanta,  GA  30339
Contactgidgette rubin
Regulation Number890.5900
Classification Product Code
ITH  
Date Received10/07/2003
Decision Date 09/09/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Orthopedic
Statement/Summary/Purged Status Statement only
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
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