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510(k) K033231

SPINA SYSTEM by North American Medical Corp (Nam) — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2005
Date Received
October 6, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type

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