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510(k) K041215

CRANIAL HELMET by Otto Bock Healthcare LP — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2004
Date Received
May 10, 2004
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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