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510(k) K111247

CRANIAL REMOLDING ORTHOSIS by Orthotic Care Services, Llp — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2011
Date Received
May 3, 2011
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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