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510(k) K070694

CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) by Mike Miner — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2007
Date Received
March 13, 2007
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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