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510(k) K063133

CRANIAL SOLUTION ORTHOSIS by Cranial Solutions — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2007
Date Received
October 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Cranial
Device Class
Class II
Regulation Number
882.5970
Review Panel
NE
Submission Type

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